Cleared Traditional

K913568 - SURGI-SPRAY O.R. IRRIGATION SYSTEM

K913568 is an FDA 510(k) clearance for SURGI-SPRAY O.R. IRRIGATION SYSTEM, manufactured by Phoenix Surgical Products, Inc.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K913568 · Phoenix Surgical Products, Inc. · General Hospital
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Nov 1991
Decision
84d
Days
Class 2
Risk

K913568 is an FDA 510(k) clearance for the SURGI-SPRAY O.R. IRRIGATION SYSTEM. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Phoenix Surgical Products, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 1, 1991 after a review of 84 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 Phoenix Surgical Products, Inc. devices

FDA 510(k) Submission Details - K913568

510(k) Number K913568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1991
Decision Date November 01, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 44
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K913568.
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
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
EXCEL PULSED IRRIGATION/SUCTION SYSTEM
K873466 · Stryker Corp. · Nov 1987