Cleared Traditional

PENTAX UPPER G.I. FIBERSCOPE, #FG-34

K810007 · Pentax Precision Instrument Corp. · Gastroenterology & Urology
Jan 1981
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K810007 is an FDA 510(k) clearance for the PENTAX UPPER G.I. FIBERSCOPE, #FG-34, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Pentax Precision Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981, 10 days after receiving the submission on January 5, 1981. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K810007 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1981
Decision Date January 15, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code GDB — Endoscope, Fiber Optic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500