Cleared Traditional

K971796 - LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS

K971796 is an FDA 510(k) clearance for LAPAROTOMY BLADDER NECK SUSPENSION KIT ..., manufactured by Louisville Laboratories, Inc.. The device is a Class 2 Orthopedic device with product code EZL cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K971796 · Louisville Laboratories, Inc. · Orthopedic device
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Aug 1997
Decision
89d
Days
Class 2
Risk

K971796 is an FDA 510(k) clearance for the LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 876.5130 - 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

FDA 510(k) Submission Details - K971796

510(k) Number K971796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date August 12, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZL Catheter, Retention Type, Balloon

All 95
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K971796.
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
K974419 · Rusch, Inc. · Jan 1998
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · Rusch Intl. · Jan 1998
RUSCH BRILLANT BALLOON CATHETER
K971643 · Rusch Intl. · Oct 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT
K971801 · Louisville Laboratories, Inc. · Jul 1997
CONTIDRAIN CATHETER
K964757 · Contimed, Inc. · Jun 1997
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
K970716 · Opticon Medical, Inc. · May 1997