Cleared Traditional

K002906 - ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07

K002906 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Dec 2000
Decision
88d
Days
-
Risk

K002906 is an FDA 510(k) clearance for the ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053.... Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 15, 2000 after a review of 88 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 Ethicon Endo-Surgery, Inc. devices

FDA 510(k) Submission Details - K002906

510(k) Number K002906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date December 15, 2000
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 106
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K002906.
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
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637 · Synergetics, Inc. · Apr 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
K000927 · Misonix, Inc. · Oct 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
K000095 · The Olympus Optical Co. · Sep 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K994280 · Ethicon Endo-Surgery, Inc. · Mar 2000