OverStitch Endoscopic Suturing System and Accessories
FDA 510(k) K181141 · Apollo Endosurgery
510(k) numberK181141
Submission
- Device name
- OverStitch Endoscopic Suturing System and Accessories
- Applicant
- Apollo Endosurgery
Austin, TX, US - Received
- May 1, 2018
- Decision date
- June 27, 2018
- 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 |
|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT SystemQTD · Special | 09/18/2023SE |
| K231553 | OverStitch NXT Endoscopic Suturing SystemOCW · Special | 06/29/2023SE |
| K210266 | OverStitch Sx Endoscopic Suturing SystemOCW · Special | 03/02/2021SE |
| K201808 | X-Tack Endoscopic HeliX Tacking SystemPKL · Traditional | 12/15/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | 08/29/2019SE |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS)OCW · Traditional | 11/15/2017SE |
| K122270 | Overtube Endoscopic Access SystemFED · Traditional | 09/28/2012SE |
| K103155 | Sumo Access and Tissue Resection SystemODC · Traditional | 10/28/2011SE |
| K082102 | Gastric Port, Models: GAP-0016-00, GAP-0018-00, GAP-0020-00FED · Traditional | 06/14/2010SESU |
| K090583 | Endoscopic Monopolar Scissors, Models EMS-235, EMS-165KGE · Traditional | 06/26/2009SE |
Questions and answers
When was OverStitch Endoscopic Suturing System and Accessories cleared by the FDA?
OverStitch Endoscopic Suturing System and Accessories (K181141) received a 510(k) decision of Substantially Equivalent on June 27, 2018, 57 days after the submission was received.
What is the product code of K181141?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.