Cleared Traditional

K961695 - ENDO-TECH LTD., TIPS
(FDA 510(k) Clearance)

K961695 · Ratio Design Lab · Obstetrics & Gynecology

Jul 1996

Decision

61d

Days

Class 2

Risk

K961695 is an FDA 510(k) clearance for the ENDO-TECH LTD., TIPS. This device is classified as a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG).

Submitted by Ratio Design Lab (Alpheretta, US). The FDA issued a Cleared decision on July 1, 1996, 61 days after receiving the submission on May 1, 1996.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number	K961695 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1996
Decision Date	July 01, 1996
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF