Smith & Nephew Suture Collet
FDA 510(k) K971939 · Smith & Nephew Endoscopy, Inc.
510(k) numberK971939
Submission
- Device name
- Smith & Nephew Suture Collet
- Applicant
- Smith & Nephew Endoscopy, Inc.
Mansfield, MA, US - Received
- May 27, 1997
- Decision date
- August 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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|---|---|---|---|
| K252400 | Endomina EZFuse systemOCW · Traditional | Endo Tools Therapeutics S.A. | 02/13/2026SE |
| K243750 | SimpleStitch Suturing SystemOCW · Traditional | Envision Endoscopy | 04/17/2025SE |
| K231240 | MaxTack Motorized Fixation DeviceOCW · Traditional | Covidien | 09/08/2023SE |
| K213271 | MedicloseTM SystemOCW · Traditional | Health Value Creation B.V., Trading AS Corporis… | 08/31/2023SE |
| K231553 | OverStitch NXT Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 06/29/2023SE |
| K211309 | endomina systemOCW · Traditional | Endo Tools Therapeutics S.A. | 12/07/2021SE |
| K201744 | Su2ura Approximation DeviceOCW · Traditional | Anchora Medical, Ltd. | 06/17/2021SE |
| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | Apollo Endosurgery, Inc. | 03/02/2021SE |
| K193652 | AbClose - Port Site Closure DeviceOCW · Traditional | Medeon Biodesign, Inc. | 03/26/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | Apollo Endosurgery | 08/29/2019SE |
More from Apollo Endosurgery
| 510(k) | Device | Decision |
|---|---|---|
| K103309 | Osteoraptor Curved 2.3 Suture AnchorsMAI · Traditional | 02/03/2011SE |
| K102660 | Bioraptor Curved 2.3 PK Suture AnchorsMBI · Traditional | 12/13/2010SE |
| K093428 | Smith & Nephew Knotless Instability AnchorMBI · Traditional | 12/17/2009SE |
| K083635 | Smith & Nephew Biosure PK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K083226 | Smith & Nephew PEEK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceHTN · Traditional | 10/21/2008SE |
| K050580 | Smith & Nephew Intelijet Fluid Management SystemsHRX · Traditional | 04/20/2005SE |
| K992396 | Biorci ScrewHWC · Traditional | 01/12/2000SE |
| K991500 | Smith & Nephew Suture LokOCW · Traditional | 07/14/1999SE |
| K972599 | Acufex Screw CannulaHWC · Traditional | 09/19/1997SE |
Questions and answers
When was Smith & Nephew Suture Collet cleared by the FDA?
Smith & Nephew Suture Collet (K971939) received a 510(k) decision of Substantially Equivalent on August 6, 1997, 71 days after the submission was received.
What is the product code of K971939?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.