Cleared Traditional

K133273 - LIGER MEDICAL ESU-110

K133273 is an FDA 510(k) clearance for LIGER MEDICAL ESU-110, manufactured by Liger Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K133273 · Liger Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
111d
Days
Class 2
Risk

K133273 is an FDA 510(k) clearance for the LIGER MEDICAL ESU-110. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Liger Medical, LLC (Salt Lake City, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Liger Medical, LLC devices

FDA 510(k) Submission Details - K133273

510(k) Number K133273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2013
Decision Date February 12, 2014
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
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 1271
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K133273.
THUNDERBEAT
K132703 · Olympus Medical Systems Corp. · May 2014
CAIMAN SEAL AND CUT TECHNOLOGY
K140839 · Aesculap, Inc. · Apr 2014
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
K140495 · Boston Scientific Corp · Apr 2014
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
K132300 · Applied Medical Resources Corp. · Jan 2014
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
K133726 · Megadyne Medical Products, Inc. · Jan 2014
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
K133167 · Intuitive Surgical, Inc. · Jan 2014