Cleared Traditional

K963076 - LAPAROSCOPIC BONE ANCHORED URETHROPEXY ...

K963076 is an FDA 510(k) clearance for LAPAROSCOPIC BONE ANCHORED URETHROPEXY ..., manufactured by Louisville Laboratories, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K963076 · Louisville Laboratories, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
240d
Days
Class 2
Risk

K963076 is an FDA 510(k) clearance for the LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (Louisville, US). The FDA issued a Cleared decision on April 4, 1997 after a review of 240 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Louisville Laboratories, Inc. devices

FDA 510(k) Submission Details - K963076

510(k) Number K963076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date April 04, 1997
Days to Decision 240 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 160d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K963076.
AMR MINI-LAPAROSCOPE
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CANNULA
K965121 · Origin Medsystems, Inc. · Mar 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc. · Mar 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
K970105 · Richard Wolf Medical Instruments Corp. · Mar 1997