Cleared Traditional

ACESSA GUIDANCE HANDPIECE

K132184 · Halt Medical, Inc. · Obstetrics & Gynecology
Apr 2014
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K132184 is an FDA 510(k) clearance for the ACESSA GUIDANCE HANDPIECE, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Halt Medical, Inc. (Brentwood, US). The FDA issued a Cleared decision on April 28, 2014, 287 days after receiving the submission on July 15, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K132184 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2013
Decision Date April 28, 2014
Days to Decision 287 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