GDB · Class II · 21 CFR 876.1500

FDA Product Code GDB: Endoscope, Fiber Optic

Leading manufacturers include Pentax Precision Instrument Corp. and Olympus Corp..

7
Total
7
Cleared
102d
Avg days
1981
Since

FDA 510(k) Cleared Endoscope, Fiber Optic Devices (Product Code GDB)

7 devices
1–7 of 7
Cleared Nov 15, 1988
OLYMPUS GF-UM3/EU-M3
K882061
Olympus Corp.
Gastroenterology & Urology · 183d
Cleared Jan 15, 1981
PENTAX UPPER G.I. FIBERSCOPE, #FG-34
K810007
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 10d

About Product Code GDB - Regulatory Context