Cleared Traditional

K864983 - CUSA SYSTEM 200 MACRO-DISSECTOR

K864983 · Cooper Lasersonics, Inc. · General & Plastic Surgery device
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Jun 1987
Decision
183d
Days
-
Risk

K864983 is an FDA 510(k) clearance for the CUSA SYSTEM 200 MACRO-DISSECTOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 23, 1987 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K864983

510(k) Number K864983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date June 23, 1987
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 K864983.
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K883091 · Sharplan Lasers, Inc. · Oct 1988
R PAK
K851203 · CooperVision, Inc. · Jul 1985
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
K852539 · Johnson & Johnson Professionals, Inc. · Jul 1985
NEEDLE GUIDE MODEL 21285A
K830753 · Hewlett-Packard Co. · Jun 1983