Cleared Traditional

TELESCOPE, RIGID ENDOSCOPE

K760177 · V. Mueller O.V. Baxter Healthcare Corp. · Gastroenterology & Urology
Aug 1976
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K760177 is an FDA 510(k) clearance for the TELESCOPE, RIGID ENDOSCOPE, a Telescope, Rigid, Endoscopic (Class II — Special Controls, product code FBP), submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976, 55 days after receiving the submission on July 6, 1976. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K760177 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1976
Decision Date August 30, 1976
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code FBP — Telescope, Rigid, Endoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

Similar Devices — FBP Telescope, Rigid, Endoscopic

OES ELITE Telescopes, Protective Tube
K151191 · Olympus Winter & Ibe GmbH · Nov 2015
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
K113062 · Endoservice Optical Instruments GmbH · Aug 2012
ACMI M4 TELESCOPES
K031758 · Acmi Corporation · Sep 2003
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
K984607 · Richard Wolf Medical Instruments Corp. · Mar 1999