510(k) K201808 ยท PKL Hemostatic Metal Clip For The Gi Tract
X-Tack Endoscopic HeliX Tacking System
| Applicant | Apollo Endosurgery, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Dec 15, 2020 |
| Received | Jul 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201808
| 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.