Cleared Traditional

K980134 - KSEA N2O ENDOFLATOR (FDA 510(k) Clearance)

K980134 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device

Apr 1998

Decision

90d

Days

Class 2

Risk

K980134 is an FDA 510(k) clearance for the KSEA N2O ENDOFLATOR. 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 April 15, 1998, 90 days after receiving the submission on January 15, 1998.

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

Submission Details

510(k) Number	K980134 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 15, 1998
Decision Date	April 15, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF