Cleared Traditional

K971802 - VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
(FDA 510(k) Clearance)

K971802 · Louisville Laboratories, Inc. · Orthopedic
Jul 1997
Decision
76d
Days
Class 2
Risk

K971802 is an FDA 510(k) clearance for the VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Louisville Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 30, 1997, 76 days after receiving the submission on May 15, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K971802 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1997
Decision Date July 30, 1997
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040