FBQ
9 FDA 510(k) clearances · Product code
64 daysmedian time to decision
133 days90th percentile
9clearances measured
FDA profile
- Official device name
- Trocar, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 7 · 1993: 8 · 1994: 6 · 1995: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GIBBONS STERILE TROCAR KITS (K012198) | Gibbons Surgical Corp. | 2001-08-09 |
| SABRE BT BLUNT0TIP SURGICAL TROCAR (K980804) | Endoscopic Concepts, Inc. | 1998-04-01 |
| LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (K944640) | Gabris Surgical Corp. | 1994-10-11 |
| GABRIS LAPAROSCOPIC SURGICAL KITS (K944104) | Gabris Surgical Corp. | 1994-09-13 |
| AUTO SUTURE MODIFIED GRIP (K942885) | United States Surgical, A Division of Tyco Healthc | 1994-08-22 |
| AESCULAP TROCAR INSTRUMENT SET (K934724) | Aesculap, Inc. | 1993-12-23 |
| TROCAR DISPOSABLE (K904638) | L.A.S.E.R., Inc. | 1991-02-21 |
| AUTO SUTURE SURGIPORT SPIRAL SLEEVE (K900123) | United States Surgical, A Division of Tyco Healthc | 1990-04-04 |
| ENDOPORT EROCAR (K841716) | Endotherapeutics | 1984-06-28 |
Track FBQ automatically
Every clearance here is in the API, with alerts when new ones post.