Cleared Traditional

K904010 - SURGICAL ASPIRATOR KIT

K904010 · Surgeon Surgical Instrumentation, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
84d
Days
-
Risk

K904010 is an FDA 510(k) clearance for the SURGICAL ASPIRATOR KIT. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Surgeon Surgical Instrumentation, Inc. (Placentia, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Surgeon Surgical Instrumentation, Inc. devices

Submission Details

510(k) Number K904010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date November 21, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 87
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K904010.
CV720-727-000, MICROTIP AND FLUE PAK
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CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
K910696 · Valleylab, Inc. · Jun 1991
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
K894600 · Valleylab, Inc. · Jan 1990
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · Sharplan Lasers, Inc. · Oct 1988
CUSA SYSTEM 200 MACRO-DISSECTOR
K864983 · Cooper Lasersonics, Inc. · Jun 1987