Cleared Traditional

K053056 - HARMONIC SCALPEL BLADES AND SHEARS

K053056 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
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.

View all Ethicon Endo-Surgery, Inc. devices

Submission Details

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.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 67
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