Modified Endo Stich
FDA 510(k) K082659 · Covidien Lp, Formerly Registered AS United States
510(k) numberK082659
Submission
- Device name
- Modified Endo Stich
- Applicant
- Covidien Lp, Formerly Registered AS United States
North Haven, CT, US - Received
- September 12, 2008
- Decision date
- September 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K091869 | Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsGCJ · Special | 09/01/2009SE |
| K091900 | Absorbatack 5MM Single Use Absorbable Fixation DeviceGDW · Special | 07/16/2009SE |
| K083519 | Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsGDW · Traditional | 04/10/2009SE |
| K090419 | Sils Stitch Endoscopic Suturing DeviceOCW · Special | 03/09/2009SE |
| K082619 | Sils Port, Models SILSPT5, SILSPT12GCJ · Traditional | 11/07/2008SE |
| K081169 | Autosuture Versaport Plus Bladless Trocar; Bladeless TrocarGCJ · Special | 05/23/2008SE |
Questions and answers
When was Modified Endo Stich cleared by the FDA?
Modified Endo Stich (K082659) received a 510(k) decision of Substantially Equivalent on September 19, 2008, 7 days after the submission was received.
What is the product code of K082659?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.