Product code FBM— Gastroenterology, Urology
CANNULA AND TROCAR, 11MM
- Classification name
- Cannula And Trocar, Suprapubic, Non-Disposable
- Device class
- Class 1
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code FBM
FDA has cleared devices under product code FBM between 1990 and 1996, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1994
- 1991
- 1990
Top applicants under product code FBM
Recent clearances under product code FBM
- K960400 — DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
- K932021 — ENTREE CANNULA FASCIA ANCHORS
- K911813 — ENTREE CANNULA
- K900955 — GS-4000 REDUCER SLEEVE, 11MM TO 5MM
- K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM
- K900962 — GS-4300 CANNULA AND TROCAR, 5.5MM
- K900963 — GS-4350 TROCAR ONLY, 5.5MM
- K900964 — CANNULA AND TROCAR, 11MM
- K900965 — GS-4550 TROCAR ONLY, 11MM
Data sourced from openFDA. This site is unofficial and independent of the FDA.