Cleared Traditional

K101606 - MICROMED PD-8K INSULATION DEFECT DETECTOR
(FDA 510(k) Clearance)

K101606 · Mcgan Technology, LLC · Obstetrics & Gynecology
Oct 2010
Decision
115d
Days
Class 2
Risk

K101606 is an FDA 510(k) clearance for the MICROMED PD-8K INSULATION DEFECT DETECTOR, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Mcgan Technology, LLC (Middletown, US). The FDA issued a Cleared decision on October 1, 2010, 115 days after receiving the submission on June 8, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K101606 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2010
Decision Date October 01, 2010
Days to Decision 115 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HFG — Coagulator, Laparoscopic, Unipolar (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4160