Cleared Traditional

SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP (K852539) - FDA 510(k) Clearance

K852539 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Jul 1985
Decision
39d
Days
-
Risk

K852539 is an FDA 510(k) clearance for the SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Johnson & Johnson Professionals, Inc. (Ramsey, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 39 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K852539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date July 23, 1985
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 38
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