FDG · Class I · 21 CFR 876.4530

FDA Product Code FDG: Retractor, Fiberoptic

Leading manufacturers include Stephen Chakoff, Inc. and Bioenterics Corp..

2
Total
2
Cleared
70d
Avg days
1994
Since

FDA 510(k) Cleared Retractor, Fiberoptic Devices (Product Code FDG)

2 devices
1–2 of 2
Cleared Feb 11, 1997
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
K964561
Bioenterics Corp.
Gastroenterology & Urology · 90d
Cleared Dec 23, 1994
CHAKOFF ENDOSCOPY
K945421
Stephen Chakoff, Inc.
Gastroenterology & Urology · 49d

About Product Code FDG - Regulatory Context