Cleared Traditional

K123444 - LIGASURE IMPACT CURVED

K123444 is an FDA 510(k) clearance for LIGASURE IMPACT CURVED, manufactured by Covidien, Formerly Valleylab, A Division of Tyco H. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K123444 · Covidien, Formerly Valleylab, A Division of Tyco H · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
83d
Days
Class 2
Risk

K123444 is an FDA 510(k) clearance for the LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Covidien, Formerly Valleylab, A Division of Tyco H (Boulder, US). The FDA issued a Cleared decision on January 30, 2013 after a review of 83 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 Covidien, Formerly Valleylab, A Division of Tyco H devices

FDA 510(k) Submission Details - K123444

510(k) Number K123444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2012
Decision Date January 30, 2013
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1355
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K123444.
OLYMPUS ENERGY POWER SYSTEM (EPS)
K123429 · Gyrus Acmi, Inc. · Apr 2013
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
K130744 · Covidien · Apr 2013
CAIMAN SEAL AND CUT TECHNOLOGY
K130596 · Aesculap, Inc. · Mar 2013
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
K122797 · Ethicon Endo-Surgery, LLC · Jan 2013
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
K123310 · Utah Medical Products, Inc. · Jan 2013
DETACHATIP III
K123260 · Conmed Corporation · Dec 2012