510(k) K011016 ยท GCJ Laparoscope, General & Plastic Surgery
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
| Applicant | Lsi Solutions, Rochester NY, US |
| Decision | Substantially Equivalent, Apr 27, 2001 |
| Received | Apr 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2005 | Wilson-Cook Medical Inc ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2 Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.