Cleared Traditional

INSIDE VIEW

K001217 · Monadnock Optics, Inc. · Gastroenterology & Urology
Jul 2000
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K001217 is an FDA 510(k) clearance for the INSIDE VIEW, a Endoscope, Rigid (Class II — Special Controls, product code GCM), submitted by Monadnock Optics, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on July 11, 2000, 85 days after receiving the submission on April 17, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K001217 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2000
Decision Date July 11, 2000
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code GCM — Endoscope, Rigid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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