Cleared Traditional

K951694 - ELECTRONIC LAPAROFLATOR (FDA 510(k) Clearance)

K951694 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device

Aug 1995

Decision

114d

Days

Class 2

Risk

K951694 is an FDA 510(k) clearance for the ELECTRONIC LAPAROFLATOR. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 4, 1995, 114 days after receiving the submission on April 12, 1995.

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

Submission Details

510(k) Number	K951694 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 12, 1995
Decision Date	August 04, 1995
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF