Cleared Traditional

K053056 - HARMONIC SCALPEL BLADES AND SHEARS

K053056 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device

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Jan 2006

Decision

80d

Days

Risk

K053056 is an FDA 510(k) clearance for the HARMONIC SCALPEL BLADES AND SHEARS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 19, 2006 after a review of 80 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 - K053056

510(k) Number	K053056 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 31, 2005
Decision Date	January 19, 2006
Days to Decision	80 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

35d faster than avg

Panel avg: 115d · This submission: 80d

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 153

Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K053056.

ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF

K062471 · Misonix, Inc. · Oct 2006

HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S

K062000 · Ethicon Endo-Surgery, Inc. · Sep 2006

HARMONIC SCALPEL BLADES AND SHEARS

K060245 · Ethicon Endo-Surgery, Inc. · Apr 2006

RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE

K051947 · Radionics, A Division of Tyco Healthcare Group LP · Aug 2005

AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

K050776 · Misonix, Inc. · Jun 2005

OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG

K050885 · Olympus Medical Systems Corporation · Jun 2005

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 K053056

Ethicon Endo-Surgery, Inc.

Cincinnati, OH · US

ELIZABETH MILLER

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: January 19, 2006. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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