Panels › Obstetrics/Gynecology › Product code PWI · Class 2
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Regulation 884.4910
0510(k)s in 12 months (2 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in PWI
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 1 | 13 |
| Coloplast A/S | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K172060 |
| 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 | K172060 |
| May 4, 2018 | Boston Scientific Corporation Uphold Vaginal Support System; Model #M0068317080.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | K081048 |
| May 4, 2018 | Boston Scientific Corporation PFR Kit- Pinnacle, Posterior; Model #M0068317100.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | K071957 |
| May 4, 2018 | Boston Scientific Corporation PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | K071957 |
| May 4, 2018 | Boston Scientific Corporation Posterior LITE w/ Capio SLIM; Model #M0068318150.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | K122459 |
| May 4, 2018 | Boston Scientific Corporation Uphold LITE w/ Capio SLIM; Model #M0068318170.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | K122459 |
| May 4, 2018 | Boston Scientific Corporation Capio RP; Model #M0068321010.
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 |
| May 4, 2018 | Boston Scientific Corporation Capio Standard Box 4 (Capio PC); Model #M0068312321.
Intended for use in general suturing applications during open or endoscopic
surgery to assist in the placement of suture material in tissues at th Terminated |
PWI | K932553 |
| May 4, 2018 | Boston Scientific Corporation Capio Open Access Box 4 (Capio OPC); Model #M0068311251.
Intended for use in general suturing applications during open or endoscopic
surgery to assist in the placement of suture material in tissues a Terminated |
PWI | None listed |
| May 4, 2018 | Boston Scientific Corporation Capio CL; Model #M0068311350.
Indicated for the placement of suture in a variety of Transvaginal procedures. Terminated |
PWI | K932553 |
| 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 | K172060 |
| 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 | K172060 |
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