Cleared Traditional

K121343 - MODULAP LOOP
(FDA 510(k) Clearance)

K121343 · Atc Technologies, Inc. · Obstetrics & Gynecology

Jun 2013

Decision

406d

Days

Class 2

Risk

K121343 is an FDA 510(k) clearance for the MODULAP LOOP. This device is classified as a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF).

Submitted by Atc Technologies, Inc. (Dover, US). The FDA issued a Cleared decision on June 14, 2013, 406 days after receiving the submission on May 4, 2012.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number	K121343 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2012
Decision Date	June 14, 2013
Days to Decision	406 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF