Product code GBT— Gastroenterology, Urology
INFLATABLE RETENTION CUFF SPECULUM
- Classification name
- Catheter, Rectal
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GBT
FDA has cleared devices under product code GBT between 1989 and 1994, filed by 3 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
- 1994
- 1989
Top applicants under product code GBT
Recent clearances under product code GBT
Data sourced from openFDA. This site is unofficial and independent of the FDA.