Cleared Traditional

K021989 - SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3

K021989 · Integra Neurosciences · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
87d
Days
-
Risk

K021989 is an FDA 510(k) clearance for the SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Neurosciences (San Diego, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 87 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 Integra Neurosciences devices

FDA 510(k) Submission Details - K021989

510(k) Number K021989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date September 13, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 117
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K021989.
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
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K021929 · Axya Medical, Inc. · Sep 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
K020220 · Synergetics, Inc. · Aug 2002
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
K012176 · Ethicon Endo-Surgery, Inc. · Oct 2001