Cleared Traditional

K971797 - LAPAROSCOPIC BLADDER NECK SUSPENSION KIT

K971797 is the FDA 510(k) clearance for LAPAROSCOPIC BLADDER NECK SUSPENSION KIT by Louisville Laboratories, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K971797 · Louisville Laboratories, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
68d
Days
Class 2
Risk

K971797 is an FDA 510(k) clearance for the LAPAROSCOPIC BLADDER NECK SUSPENSION KIT. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 22, 1997 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device 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 K971797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 160d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 151
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K971797.
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
K971836 · CooperSurgical, Inc. · Nov 1997
AMR MINI-LAPAROSCOPE
K962777 · Applied Medical Resources · Aug 1997
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
K971837 · CooperSurgical, Inc. · Aug 1997
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
K965045 · Ethicon Endo-Surgery, Inc. · May 1997
CANNULA
K965121 · Origin Medsystems, Inc. · Mar 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc. · Mar 1997