Cleared Traditional

K955810 - U-TEX
(FDA 510(k) Clearance)

K955810 · Laborie Medical Technologies, Ltd. · Gastroenterology & Urology device

Jan 1996

Decision

29d

Days

Class 1

Risk

K955810 is an FDA 510(k) clearance for the U-TEX. This device is classified as a Clamp, Penile (Class I - General Controls, product code FHA).

Submitted by Laborie Medical Technologies, Ltd. (Mississauga, CA). The FDA issued a Cleared decision on January 24, 1996, 29 days after receiving the submission on December 26, 1995.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5160.

Submission Details

510(k) Number	K955810 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 26, 1995
Decision Date	January 24, 1996
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement