Cleared Special

K990430 - ULTRACISION HARMONIC SCALPEL HAND PIECE

K990430 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Mar 1999

Decision

29d

Days

Risk

K990430 is an FDA 510(k) clearance for the ULTRACISION HARMONIC SCALPEL HAND PIECE. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 12, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990430

510(k) Number	K990430 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 11, 1999
Decision Date	March 12, 1999
Days to Decision	29 days
Submission Type	Special
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

86d faster than avg

Panel avg: 115d · This submission: 29d

Pathway characteristics

Modification to existing cleared device.

LFL Device Classification - Class 0,

Product Code	LFL Instrument, Ultrasonic Surgical
Device Class	-

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 153

Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K990430.

ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141

K993054 · Ethicon Endo-Surgery, Inc. · Dec 1999

SOUND VASER SYSTEM

K991791 · Sound Surgical Technologies, LLC · Aug 1999

SONOTOME

K990572 · Sonokinetics, Inc. · May 1999

FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL

K983199 · Fibra Sonics, Inc. · Dec 1998

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM

K983065 · Mentor Corp. · Dec 1998

ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR

K980895 · California Institute of Tissue Eng. & Instrumenti · Nov 1998

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K990430

Ethicon Endo-Surgery, Inc.

Cincinnati, OH · US

RUTH ANN WOOD

Regulatory profile

112 submissions 112 cleared

100% clearance rate · Active in General & Plastic Surgery

View all devices by Ethicon Endo-Surgery, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: March 12, 1999. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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