Cleared Traditional

K972069 - STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK

K972069 is an FDA 510(k) clearance for STRYKER INTERPULSE HANDPIECE SET, manufactured by Stryker Instruments. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K972069 · Stryker Instruments · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
56d
Days
Class 2
Risk

K972069 is an FDA 510(k) clearance for the STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS.... Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 56 days - a notably fast clearance cycle.

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: 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 Stryker Instruments devices

FDA 510(k) Submission Details - K972069

510(k) Number K972069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1997
Decision Date July 29, 1997
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K972069.
FLEXVIEW CO2 BLOWER WITH MIST
K973803 · Ethicon Endo-Surgery, Inc. · Dec 1997
CLEARVIEW BLOWER/MISTER
K973485 · Dlp, Inc. · Dec 1997
ARTISAN PULSE LAVAGE SYSTEM
K972551 · Howmedica Corp. · Oct 1997
H.V. PULSE LAVAGE (L31 SERIES)
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
SIMPULSE SOLO SUCTION IRRIGATOR
K942886 · Davol Inc., Sub. C. R. Bard, Inc. · Jul 1994