Cleared Traditional

K971802 - VAGINAL SUTURING KIT FOR BLADDER NECK S...

K971802 is the FDA 510(k) clearance for VAGINAL SUTURING KIT FOR BLADDER NECK S... by Louisville Laboratories, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K971802 · Louisville Laboratories, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
76d
Days
Class 2
Risk

K971802 is an FDA 510(k) clearance for the VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 30, 1997 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Louisville Laboratories, Inc. devices

Submission Details

510(k) Number K971802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K971802.
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K971139 · Boston Scientific Corp · Jun 1997