Cleared Traditional

K010637 - SONOTOME ULTRASONIC ASPIRATOR TIPS

K010637 · Synergetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
46d
Days
-
Risk

K010637 is an FDA 510(k) clearance for the SONOTOME ULTRASONIC ASPIRATOR TIPS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Synergetics, Inc. (St. Charles, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 46 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 Synergetics, Inc. devices

FDA 510(k) Submission Details - K010637

510(k) Number K010637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date April 20, 2001
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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 122
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K010637.
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
K012176 · Ethicon Endo-Surgery, Inc. · Oct 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
K012028 · Misonix, Inc. · Jul 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898 · Ethicon Endo-Surgery, Inc. · May 2001
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
K002906 · Ethicon Endo-Surgery, Inc. · Dec 2000
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
K000927 · Misonix, Inc. · Oct 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
K000095 · The Olympus Optical Co. · Sep 2000