Cleared Traditional

K971797 - LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
(FDA 510(k) Clearance)

K971797 · Louisville Laboratories, Inc. · Obstetrics & Gynecology

Jul 1997

Decision

68d

Days

Class 2

Risk

K971797 is an FDA 510(k) clearance for the LAPAROSCOPIC BLADDER NECK SUSPENSION KIT, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Louisville Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 22, 1997, 68 days after receiving the submission on May 15, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number	K971797 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 1997
Decision Date	July 22, 1997
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF