Cleared Traditional

K161554 - ENDOFLATOR 40, ENDOFLATOR 50 (FDA 510(k) Clearance)

K161554 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device

Mar 2017

Decision

269d

Days

Class 2

Risk

K161554 is an FDA 510(k) clearance for the ENDOFLATOR 40, ENDOFLATOR 50. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on March 2, 2017, 269 days after receiving the submission on June 6, 2016.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number	K161554 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 2016
Decision Date	March 02, 2017
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF