510(k) K932553 ยท GCJ Laparoscope, General & Plastic Surgery
DISPOSABLE SUTURE PLACEMENT SYSTEM
| Applicant | Laurus Medical Corp., Irvine CA, US |
| Decision | Substantially Equivalent, May 12, 1994 |
| Received | May 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Boston Scientific Corporation Capio CL; Model #M0068311350.
Indicated for the placement of suture in a variety of Transvaginal procedures. 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.