Cleared Traditional

K951666 - STRYKER INTERPULSE HANDPIECE SET

K951666 is the FDA 510(k) clearance for STRYKER INTERPULSE HANDPIECE SET by Stryker Instruments. It is a Class 2 General Hospital device (product code FQH) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K951666 · Stryker Instruments · General Hospital
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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

Submission Details

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.

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 K951666.
CLEARVIEW BLOWER/MISTER
K973485 · Dlp, Inc. · Dec 1997
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
RMI SURGICCAL SITE VISUALIZATION WAND
K922083 · Research Medical, Inc. · Jan 1993
PHARMASEAL WOUND IRRIGATION DEVICE
K874022 · American Pharmaseal Div. Ahsc · Dec 1987
MICRO-AIRE PULSE LAVAGE
K874504 · Micro-Aire Surgical Instruments, Inc. · Dec 1987