510(k) K181141 ยท OCW Endoscopic Tissue Approximation Device
OverStitch Endoscopic Suturing System and Accessories
| Applicant | Apollo Endosurgery, Austin TX, US |
| Decision | Substantially Equivalent, Jun 27, 2018 |
| Received | May 1, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181141
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Boston Scientific Corporation OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. Open, Classified |
OCW | None listed |
| Aug 14, 2026 | Boston Scientific Corporation Suture Cinch Long 1pk. Endoscopic tissue approximation device. Open, Classified |
OCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.