Table And Attachments, Operating-Room
FDA product code BWN · Class I (low risk) · 21 CFR 878.4950 · General, Plastic Surgery
20510(k) clearances
0PMA approvals
74recalls
Manufacturers
- Northwest Surgical Concepts, Inc. 2
- Edgewater Medical Equipment Systems 1
- Alpha Surgical, Inc. 1
- Infinitech, Inc. 1
- Instrumentation Specialties, Inc. 1
- Yamashita and Hemsley Business Trust 1
- Smith & Nephew Equipment Group 1
- Sds Dental, Inc. 1
- Mend Technologies, Inc. 1
- T. Korossurgical Instruments Corp. 1
- Stierlen-Maquet AG 1
- Tecnol New Jersey Wound Care, Inc. 1
- Scholten Surgical Instruments, Inc. 1
- Dyonics, Inc. 1
- Kamiya Tsusan Kaisha, Ltd. 1
- American Sterilizer Co. 1
- David Simmonds Co., Inc. 1
- The Anspach Effort, Inc. 1
- Ets Rene Marzet 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942699 | Airframe Surgical Drape SupportBWN · Traditional | Alpha Surgical, Inc. | 07/13/1994SE |
| K935441 | Infinitech Breath EzBWN · Traditional | Infinitech, Inc. | 02/07/1994SE |
| K925005 | Isi Self-Supporting ArmBWN · Traditional | Instrumentation Specialties, Inc. | 04/29/1993SE |
| K922288 | Holder, Pediatric PositionBWN · Traditional | Yamashita and Hemsley Business Trust | 02/10/1993SE |
| K910783 | Shampaine Model 3800 or Muranaka Model OR-604MBWN · Traditional | Smith & Nephew Equipment Group | 04/02/1991SE |
| K902865 | Baumer Surgical TableBWN · Traditional | Sds Dental, Inc. | 09/10/1990SE |
| K884558 | Iop Adjustable StirrupBWN · Traditional | Mend Technologies, Inc. | 11/17/1988SE |
| K875291 | Spinal Surgery FrameBWN · Traditional | T. Korossurgical Instruments Corp. | 01/22/1988SE |
| K873272 | Endoscopy Table 1532 EndostarBWN · Traditional | Stierlen-Maquet AG | 09/08/1987SE |
| K860177 | Allen Universal StirrupBWN · Traditional | Edgewater Medical Equipment Systems | 02/11/1986SE |
| K852332 | Table Accessories, Operating RoomBWN · Traditional | Scholten Surgical Instruments, Inc. | 07/02/1985SE |
| K843121 | Guide to the KneeBWN · Traditional | Dyonics, Inc. | 09/07/1984SE |
| K832340 | Operating Room Tables HydraulicBWN · Traditional | Kamiya Tsusan Kaisha, Ltd. | 08/12/1983SE |
| K823772 | Amsco Orthographic 2 TableBWN · Traditional | American Sterilizer Co. | 01/14/1983SE |
| K820574 | Armboard for Intravenous Anes. in DentalBWN · Traditional | David Simmonds Co., Inc. | 03/23/1982SE |
| K812396 | Arthro-Prep RestBWN · Traditional | Northwest Surgical Concepts, Inc. | 11/20/1981SE |
| K812395 | Arthro-Prep Rest W/StandBWN · Traditional | Northwest Surgical Concepts, Inc. | 11/20/1981SE |
| K802271 | The Immobilizer for Open & ArthroscopicBWN · Traditional | The Anspach Effort, Inc. | 10/23/1980SE |
| K792569 | Operating Tables & Amplinox 03BWN · Traditional | Ets Rene Marzet | 01/04/1980SE |
| K791859 | Tecnol Stirrups StrapBWN · Traditional | Tecnol New Jersey Wound Care, Inc. | 10/04/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0072-2022 Class II | ARCH Leg Positioning SystemDue to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. | Innovative Orthopedic Technologies, LLC | 09/13/2021Terminated |
| Z-2032-2017 Class II | 20.2cm Heavy Duty Long Heavy Short AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2031-2017 Class II | Sagittal MICRO-SAWSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2030-2017 Class II | 5.0cm Heavy Duty Short AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2029-2017 Class II | 5.0cm Short AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2028-2017 Class II | SMALL ATTACHMENT, J-LATCHSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2027-2017 Class II | SMALL ATTACHMENT, JACOBS CHUCKSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2026-2017 Class II | Reciprocating MICRO SAWSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2025-2017 Class II | 7.5cm QD Angle AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2024-2017 Class II | 8cm QD Angle AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2023-2017 Class II | 14cm QD Angle AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2022-2017 Class II | 14cm QD Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2021-2017 Class II | 10.5cm QD Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2020-2017 Class II | 11cm QD Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2019-2017 Class II | Oscillating MICRO-SAW Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2018-2017 Class II | 90 degree Contra Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2017-2017 Class II | 45 degree Contra Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2016-2017 Class II | Otologic Curved Micro Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2015-2017 Class II | Sagittal Saw Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2014-2017 Class II | 16cm Minimally Invasive Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2013-2017 Class II | 8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2012-2017 Class II | 8.0cm Medium Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2011-2017 Class II | Minimal Access Straight Driver Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2010-2017 Class II | Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2009-2017 Class II | Minimal Access Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2008-2017 Class II | Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2007-2017 Class II | Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2006-2017 Class II | Bearing Sleeve, 15CM Straight Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2005-2017 Class II | Bearing Sleeve, 15CM Curved Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2004-2017 Class II | Bearing Sleeve, 10CM Straight Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2003-2017 Class II | Bearing Sleeve, 10CM Curved Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2002-2017 Class II | 10.5cm Long Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2001-2017 Class II | 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2000-2017 Class II | 10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1999-2017 Class II | 11.0cm Long Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1995-2017 Class II | Keyless Driver Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1994-2017 Class II | Chuck Driver SystemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1993-2017 Class II | Compact Speed Reducer, 60:1 Black MaxSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1992-2017 Class II | Compact Speed Reducer, 60:1Supplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1991-2017 Class II | Pediatric CraniotomeSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1990-2017 Class II | Rotating Large CraniotomeSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1989-2017 Class II | Large Craniotome Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1988-2017 Class II | Rotating Adult Craniotome Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1987-2017 Class II | 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1986-2017 Class II | Adult Craniotome Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1985-2017 Class II | 6.8cm Controlled Depth Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1984-2017 Class II | 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1983-2017 Class II | PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1982-2017 Class II | 5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1981-2017 Class II | 12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |