Cleared Traditional

K042777 - HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P

K042777 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device

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Dec 2004

Decision

56d

Days

Risk

K042777 is an FDA 510(k) clearance for the HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 56 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.

FDA 510(k) Submission Details - K042777

510(k) Number	K042777 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 06, 2004
Decision Date	December 01, 2004
Days to Decision	56 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

59d faster than avg

Panel avg: 115d · This submission: 56d

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 152

Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K042777.

OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG

K050885 · Olympus Medical Systems Corporation · Jun 2005

HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P

K051036 · Ethicon Endo-Surgery, Inc. · Jun 2005

SONOSURG TROCAR

K042160 · Aomori Olympus Co., Ltd. · Jan 2005

SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM

K042277 · Integra Neurosciences, Ltd. · Sep 2004

SONOSURG ULTRASONIC SURGICAL SYSTEM

K041566 · Aomori Olympus Co., Ltd. · Sep 2004

LOTUS

K032424 · Sra Developments, Ltd. · Dec 2003

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 K042777

Ethicon Endo-Surgery, Inc.

Cincinnati, OH · US

KIMBERLY SHOEMAKER

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: December 1, 2004. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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