Cleared Traditional

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

K852539 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 114d · 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 156
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K852539.
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
Ultrasonic Surgical System
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Jun 2024