510(k) K172060 ยท PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Capio SLIM Suture Capturing Device
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Nov 3, 2017 |
| Received | Jul 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2024 | Boston Scientific Corporation Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260.
Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent pl Open, Classified |
PWI | None listed |
| Jul 30, 2024 | Boston Scientific Corporation Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250.
Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedur Open, Classified |
PWI | None listed |
| May 4, 2018 | Boston Scientific Corporation Capio SLIM Suture Capturing Device, Model #M0068318250.
Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative Terminated |
PWI | None listed |
| May 4, 2018 | Boston Scientific Corporation Capio SLIM Box 5, Model #M0068318261;
Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site. Terminated |
PWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.