Knee Support for X-Ray & Surgery
FDA 510(k) K820291 · The Anspach Effort, Inc.
510(k) numberK820291
Submission
- Device name
- Knee Support for X-Ray & Surgery
- Applicant
- The Anspach Effort, Inc.
Mchenry, IL, US - Received
- February 3, 1982
- Decision date
- March 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWZ – Operating Room Accessories Table Tray
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Other 510(k)s with product code FWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960019 | Retractor Arm ClampFWZ · Traditional | Biopsys Medical, Inc. | 02/09/1996SE |
| K945415 | 'Lil Mac Accessory Clamp(Tm)FWZ · Traditional | D.L. Nelson and Assoc., Inc. | 11/22/1994SE |
| K944779 | Carbon Lights Hand Surgery TableFWZ · Traditional | Allen Medical Systems, Inc. | 10/14/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | Andronic Devices, Ltd. | 04/15/1994SE |
| K931037 | Whitmore Vacuum-Lock Spinal Frame (VLSF-100)FWZ · Traditional | Whitmore Ent., Inc. | 07/30/1993SE |
| K926225 | Sponge CounterFWZ · Traditional | American Medical Manufacturer, Inc. | 03/05/1993SE |
| K925035 | Midkiff Geostatic ClampFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 02/18/1993SE |
| K905565 | Lateral Buttress SupportFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | Orthopedic Systems, Inc. | 01/24/1991SE |
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| 510(k) | Device | Decision |
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| K183545 | Anspach Helix Dissection ToolsHBE · Traditional | 07/19/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | 03/27/2018SE |
| K133604 | Anspach EG1 High Speed System, G1 AttachmentsHBC · Special | 01/10/2014SE |
| K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemERL · Traditional | 12/31/2013SE |
| K113476 | Anspach Dissection ToolsHBE · Special | 12/16/2011SE |
| K082637 | Cranial PerforatorHBF · Traditional | 12/22/2008SE |
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…HBE · Special | 04/30/2008SE |
| K061297 | Anspach Imri Safe Surgical Drill SystemHBB · Traditional | 01/26/2007SE |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | 01/16/2007SE |
Questions and answers
When was Knee Support for X-Ray & Surgery cleared by the FDA?
Knee Support for X-Ray & Surgery (K820291) received a 510(k) decision of Substantially Equivalent on March 5, 1982, 30 days after the submission was received.
What is the product code of K820291?
The FDA product code is FWZ – Operating Room Accessories Table Tray, a Class I (low risk) device regulated under 21 CFR 878.4950.