Autosuture Endoscopic Suturing Device
FDA 510(k) K934738 · United States Surgical, A Division of Tyco Healthc
510(k) numberK934738
Submission
- Device name
- Autosuture Endoscopic Suturing Device
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- October 1, 1993
- Decision date
- March 16, 1994
- 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.
Other 510(k)s with product code OCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K071406 | Autosuture Endo Clip III 5 MM Clip ApplierFZP · Traditional | 11/21/2007SE |
| K071920 | Autosuture Absorbable Tack and ApplicatorGDW · Traditional | 09/28/2007SE |
| K061288 | Auto Suture Endo Clip III 5 MM Clip ApplierFZP · Special | 11/02/2006SE |
| K062850 | Autosuture Circular Eea Surgical StaplersGDW · Special | 10/23/2006SE |
| K062326 | Autosuture Modified Versaport Trocar with Fixation SleeveGCJ · Special | 09/01/2006SE |
| K061095 | Auto Sutur Endo Gia StaplersGDW · Traditional | 05/31/2006SE |
| K050947 | Modification to: Modified Uss Polypropylene SutureGAW · Special | 06/01/2005SE |
| K042412 | Modified Spacemaker SystemGCJ · Special | 09/24/2004SE |
| K040594 | Herculon Soft Tissue Reattachment SystemHWC · Special | 03/31/2004SE |
| K032696 | Auto Suture Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…GDW · Traditional | 12/01/2003SE |
Questions and answers
When was Autosuture Endoscopic Suturing Device cleared by the FDA?
Autosuture Endoscopic Suturing Device (K934738) received a 510(k) decision of Substantially Equivalent on March 16, 1994, 166 days after the submission was received.
What is the product code of K934738?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.