Andover, MA, US · 2 510(k) clearances · 2 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OWY | — | — | — | 1 | 2023-05-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology, Urology | 1 | 2022-10-20 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-06-04 | P210034-S001 | Agili-C | Normal 180 Day Track No User Fee | QRU | Implant, Resorbable, For Articular Osteochondral Repair | Unknown |
| 2022-03-29 | P210034 | Agili-C | Original | QRU | Implant, Resorbable, For Articular Osteochondral Repair | Unknown |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-05-11 | K222501 | Regeneten Bioinductive Implant | OWY | — | — |
| 2022-10-20 | K221740 | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) | GCJ | Class II | Gastroenterology, Urology |