Cleared Traditional

K915743 - SHARPE ENDOTENACULUM
(FDA 510(k) Clearance)

K915743 · Paladin Medical, Inc. · Obstetrics & Gynecology

May 1993

Decision

514d

Days

Class 2

Risk

K915743 is an FDA 510(k) clearance for the SHARPE ENDOTENACULUM. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET).

Submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on May 20, 1993, 514 days after receiving the submission on December 23, 1991.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number	K915743 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1991
Decision Date	May 20, 1993
Days to Decision	514 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF