Cleared Traditional

THERMAL COAGULATOR

K870705 · Microvasive · Gastroenterology & Urology
Apr 1987
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K870705 is an FDA 510(k) clearance for the THERMAL COAGULATOR, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on April 17, 1987, 56 days after receiving the submission on February 20, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K870705 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 1987
Decision Date April 17, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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