Product code FEC— Gastroenterology, Urology
INTRODUCER SHEATH
- Classification name
- Obturator, For Endoscope
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FEC
FDA has cleared devices under product code FEC between 1976 and 2000, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1976
Top applicants under product code FEC
Recent clearances under product code FEC
Data sourced from openFDA. This site is unofficial and independent of the FDA.