Tecnol Stirrups Strap
FDA 510(k) K791859 · Tecnol New Jersey Wound Care, Inc.
510(k) numberK791859
Submission
- Device name
- Tecnol Stirrups Strap
- Applicant
- Tecnol New Jersey Wound Care, Inc.
Hammonton, NJ, US - Received
- September 18, 1979
- Decision date
- October 4, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWN – Table And Attachments, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BWN
| 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 |
More from Edgewater Medical Equipment Systems
| 510(k) | Device | Decision |
|---|---|---|
| K913043 | Modification Tecnol Fluidshield Surgical MasksFXX · Traditional | 08/23/1991SE |
| K911891 | Fluidshield(Tm) Cone Classic(Tm) II Surgical MaskFXX · Traditional | 07/12/1991SE |
| K911907 | Fluidshield Cone Classic II Surg Mask W/Splash VisFXX · Traditional | 07/08/1991SE |
| K896193 | Tecnol Lazer(Tm) Surgical MaskFXX · Traditional | 02/27/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | 07/25/1989SE |
| K893702 | Tecnol Gaiters Product Number 47725-010FXP · Traditional | 06/23/1989SE |
| K891187 | Tecnol Naso-Gastric Tube HolderBSS · Traditional | 05/30/1989SE |
| K891178 | Tecnol Secure-All Tube HolderEYZ · Traditional | 05/23/1989SE |
| K884440 | Tecnol Variable Tension BandageNAD · Traditional | 01/17/1989SN |
| K882640 | Tecnol Secure-All Pelvic Traction BeltKQZ · Traditional | 07/27/1988SE |
Questions and answers
When was Tecnol Stirrups Strap cleared by the FDA?
Tecnol Stirrups Strap (K791859) received a 510(k) decision of Substantially Equivalent on October 4, 1979, 16 days after the submission was received.
What is the product code of K791859?
The FDA product code is BWN – Table And Attachments, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4950.