Cleared Traditional

K993054 - ULTRACISION HARMONIC SCALPEL COAGULATIN...

K993054 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1999
Decision
87d
Days
-
Risk

K993054 is an FDA 510(k) clearance for the ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23.... Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 9, 1999 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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K993054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date December 09, 1999
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 67
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K993054.
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
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K994280 · Ethicon Endo-Surgery, Inc. · Mar 2000
ULTRACISION HARMONIC SCALPEL HAND PIECE
K990430 · Ethicon Endo-Surgery, Inc. · Mar 1999
ULTRACISION 5MM INSTRUMENTS
K983316 · Ethicon Endo-Surgery, Inc. · Oct 1998
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K981262 · Valleylab, Inc. · Jul 1998