Misgav, IL · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | Class II | General, Plastic Surgery | 1 | 2025-12-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-09-22 | Class II | Terminated | Z-0398-2021 | TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures,… | — | Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). |