Cleared Traditional

TUBALGATOR

K113080 · Mectra Labs, Inc. · Obstetrics & Gynecology
Jun 2012
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K113080 is an FDA 510(k) clearance for the TUBALGATOR, a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II — Special Controls, product code HIN), submitted by Mectra Labs, Inc. (Bloomfield, US). The FDA issued a Cleared decision on June 29, 2012, 255 days after receiving the submission on October 18, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4150.

Submission Details

510(k) Number K113080 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2011
Decision Date June 29, 2012
Days to Decision 255 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HIN — Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4150

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