Cleared Traditional

ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 (K040641) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040641 · Epicor Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
56d
Days
Class 2
Risk

K040641 is an FDA 510(k) clearance for the ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-.... Classified as System, Ablation, Ultrasound And Accessories (product code NTB), Class II - Special Controls.

Submitted by Epicor Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 5, 2004 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. 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 Epicor Medical, Inc. devices

Submission Details

510(k) Number K040641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date May 05, 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
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTB System, Ablation, Ultrasound And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Intended For Use As A Surgical Tool For Coagulation And Ablation Of Soft Tissue. This Differs From The Description In The Regulation In That This Device Is Not Intended To Cut Tissue And This Device Uses High Intensity Ultrasound Energy Instead Of Electrosurgery Or Electrocautery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.