Cleared Traditional

OLYMPUS GF-UM3/EU-M3

K882061 · Olympus Corp. · Gastroenterology & Urology
Nov 1988
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K882061 is an FDA 510(k) clearance for the OLYMPUS GF-UM3/EU-M3, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on November 15, 1988, 183 days after receiving the submission on May 16, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K882061 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1988
Decision Date November 15, 1988
Days to Decision 183 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