Cleared Traditional

K972551 - ARTISAN PULSE LAVAGE SYSTEM

K972551 is an FDA 510(k) clearance for ARTISAN PULSE LAVAGE SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K972551 · Howmedica Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
113d
Days
Class 2
Risk

K972551 is an FDA 510(k) clearance for the ARTISAN PULSE LAVAGE SYSTEM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on October 29, 1997 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

FDA 510(k) Submission Details - K972551

510(k) Number K972551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1997
Decision Date October 29, 1997
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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 General Hospital devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 39
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K972551.
CHASE ANASTOMOSIS VISUALIZATION DEVICE
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K970916 · Global Medical Products, Inc. · Jun 1997
STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS
K951666 · Stryker Instruments · Sep 1995