Cleared Traditional

K141288 - VOYANT ELECTROSURGICAL GENERATOR

K141288 is an FDA 510(k) clearance for VOYANT ELECTROSURGICAL GENERATOR, manufactured by Applied Medical Resources. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K141288 · Applied Medical Resources · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
98d
Days
Class 2
Risk

K141288 is an FDA 510(k) clearance for the VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Applied Medical Resources (Rancho Santa, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 98 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K141288

510(k) Number K141288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2014
Decision Date August 22, 2014
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 1297
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K141288.
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
K140008 · Terumo Cardiovascular Systems Corporation · Oct 2014
Barrx RFA Self Sizing Balloon Catheter
K142364 · Covidien, LLC · Oct 2014
HARMONIC SCALLOP BLADE, GENERATOR G11
K141122 · Ethicon Endo-Surgery, LLC · Sep 2014
LIGASURE
K141153 · Covidien · Aug 2014
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD
K141225 · Olympus Winter & Ibe GmbH · Aug 2014
VAPR ARCTIC SUCTION ELECTRODE
K140896 · Depuy Mitek, A Johnson & Johnson Company · Aug 2014