Product code FDG— Gastroenterology, Urology

CHAKOFF ENDOSCOPY

Classification name: Retractor, Fiberoptic
Device class: Class 1
Regulation: 21 CFR 876.4530
Advisory panel: Gastroenterology, Urology
Total cleared: 2
First cleared: 1994-12-23
Most recent: 1997-02-11

Market context for product code FDG

FDA has cleared 2 devices under product code FDG between 1994 and 1997, filed by 2 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

19971 clearance
19941 clearance

Top applicants under product code FDG

Stephen Chakoff, Inc.1 clearance
Bioenterics Corp.1 clearance

Recent clearances under product code FDG

K964561 — ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TABioenterics Corp.·1997-02-11
K945421 — CHAKOFF ENDOSCOPYStephen Chakoff, Inc.·1994-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.