Cleared Traditional

K032690 - MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM

K032690 · Misonix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
98d
Days
-
Risk

K032690 is an FDA 510(k) clearance for the MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on December 9, 2003 after a review of 98 days - within the typical 510(k) review window.

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 Misonix, Inc. devices

FDA 510(k) Submission Details - K032690

510(k) Number K032690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date December 09, 2003
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
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 145
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K032690.
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777 · Ethicon Endo-Surgery, Inc. · Dec 2004
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
K042277 · Integra Neurosciences, Ltd. · Sep 2004
SONOSURG ULTRASONIC SURGICAL SYSTEM
K041566 · Aomori Olympus Co., Ltd. · Sep 2004
SONOSURG SYSTEM
K032066 · The Olympus Optical Co. · Oct 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305 · Olympus Optical Co., Ltd. · Sep 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K021962 · The Olympus Optical Co. · Feb 2003