Cleared Traditional

ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.

K872630 · Hgm, Inc. · Gastroenterology & Urology
Aug 1987
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K872630 is an FDA 510(k) clearance for the ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO., a Laser For Gastro-urology Use (Class II — Special Controls, product code LNK), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 25, 1987, 50 days after receiving the submission on July 6, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K872630 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1987
Decision Date August 25, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code LNK — Laser For Gastro-urology Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4810

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