Cleared Traditional

K110294 - HIGH FLOW INSUFFLATION UNIT UHI-4 (FDA 510(k) Clearance)

K110294 · Olympus Medical Systems Corporation · Obstetrics & Gynecology device

Nov 2011

Decision

290d

Days

Class 2

Risk

K110294 is an FDA 510(k) clearance for the HIGH FLOW INSUFFLATION UNIT UHI-4. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on November 18, 2011, 290 days after receiving the submission on February 1, 2011.

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

Submission Details

510(k) Number	K110294 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 2011
Decision Date	November 18, 2011
Days to Decision	290 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF