Cleared Traditional

K873466 - EXCEL PULSED IRRIGATION/SUCTION SYSTEM

K873466 is an FDA 510(k) clearance for EXCEL PULSED IRRIGATION/SUCTION SYSTEM, manufactured by Stryker Corp.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K873466 · Stryker Corp. · General Hospital
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Nov 1987
Decision
70d
Days
Class 2
Risk

K873466 is an FDA 510(k) clearance for the EXCEL PULSED IRRIGATION/SUCTION SYSTEM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 70 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.

FDA 510(k) Submission Details - K873466

510(k) Number K873466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1987
Decision Date November 06, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
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 52
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K873466.
SURGI-SPRAY O.R. IRRIGATION SYSTEM
K913568 · Phoenix Surgical Products, Inc. · Nov 1991
PHARMASEAL WOUND IRRIGATION DEVICE
K874022 · American Pharmaseal Div. Ahsc · Dec 1987
MICRO-AIRE PULSE LAVAGE
K874504 · Micro-Aire Surgical Instruments, Inc. · Dec 1987
SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG
K854737 · Orthopaedic Devices , Ltd. · May 1986
PULSE LAVAGE
K854543 · Tava Surgical Instruments · Jan 1986
DAVOL SURGICAL SUCTION IRRIGATION INSTR
K830386 · C.R. Bard, Inc. · Mar 1983
K873466 · EXCEL PULSED IRRIGATION/SUCTION SYSTEM
Download PDF Stryker Corp.