Cleared Traditional

K894600 - CUSA SYSTEM 200C

K894600 · Valleylab, Inc. · General & Plastic Surgery device
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Jan 1990
Decision
183d
Days
-
Risk

K894600 is an FDA 510(k) clearance for the CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Valleylab, Inc. devices

FDA 510(k) Submission Details - K894600

510(k) Number K894600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date January 19, 1990
Days to Decision 183 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 115d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 88
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K894600.
CV720-727-000, MICROTIP AND FLUE PAK
K933239 · Valleylab, Inc. · Oct 1993
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
K921251 · Valleylab, Inc. · Jun 1992
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
K910696 · Valleylab, Inc. · Jun 1991
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · Sharplan Lasers, Inc. · Oct 1988
CUSA SYSTEM 200 MACRO-DISSECTOR
K864983 · Cooper Lasersonics, Inc. · Jun 1987
R PAK
K851203 · CooperVision, Inc. · Jul 1985