Cleared Special

K990430 - ULTRACISION HARMONIC SCALPEL HAND PIECE (FDA 510(k) Clearance)

K990430 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Ethicon Endo-Surgery, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 156
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K990430.
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
Ultrasonic Surgical System
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Jun 2024