Cleared Traditional

K951666 - STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS

K951666 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 162-day FDA review.

K951666 · Stryker Instruments · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
162d
Days
Class 2
Risk

K951666 is an FDA 510(k) clearance for the STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISI.... Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 162 days - an extended review 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: 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 Stryker Instruments devices

FDA 510(k) Submission Details - K951666

510(k) Number K951666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date September 19, 1995
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 K951666.
ARTISAN PULSE LAVAGE SYSTEM
K972551 · Howmedica Corp. · Oct 1997
STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
K972069 · Stryker Instruments · Jul 1997
H.V. PULSE LAVAGE (L31 SERIES)
K970916 · Global Medical Products, Inc. · Jun 1997
SIMPULSE SOLO SUCTION IRRIGATOR
K942886 · Davol Inc., Sub. C. R. Bard, Inc. · Jul 1994
RMI SURGICCAL SITE VISUALIZATION WAND
K922083 · Research Medical, Inc. · Jan 1993
PHARMASEAL WOUND IRRIGATION DEVICE
K874022 · American Pharmaseal Div. Ahsc · Dec 1987