Cleared Traditional

K972551 - ARTISAN PULSE LAVAGE SYSTEM

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

K972551 · Howmedica Corp. · General Hospital
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 31
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K972551.
HELIX HYDRO-JET
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K972069 · Stryker Instruments · Jul 1997
STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS
K951666 · Stryker Instruments · Sep 1995
RMI SURGICCAL SITE VISUALIZATION WAND
K922083 · Research Medical, Inc. · Jan 1993