Cleared Traditional

K934114 - KARL STORZ ELECTRONIC LAPAROFLATOR (FDA 510(k) Clearance)

K934114 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device

May 1994

Decision

258d

Days

Class 2

Risk

K934114 is an FDA 510(k) clearance for the KARL STORZ 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 May 10, 1994, 258 days after receiving the submission on August 25, 1993.

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

Submission Details

510(k) Number	K934114 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 25, 1993
Decision Date	May 10, 1994
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF