Cleared Traditional

K123201 - AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER

K123201 is an FDA 510(k) clearance for AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPO..., manufactured by Medtronic Advanced Energy, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K123201 · Medtronic Advanced Energy, LLC · General & Plastic Surgery device
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Jan 2013
Decision
90d
Days
Class 2
Risk

K123201 is an FDA 510(k) clearance for the AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Medtronic Advanced Energy, LLC (Portsmouth, US). The FDA issued a Cleared decision on January 10, 2013 after a review of 90 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 Medtronic Advanced Energy, LLC devices

FDA 510(k) Submission Details - K123201

510(k) Number K123201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2012
Decision Date January 10, 2013
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 1748
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K123201.
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+)
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KOGENT BIPOLAR FORCEPS
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DETACHATIP III
K123260 · Conmed Corporation · Dec 2012
AMBIENT TURBOFLASH 90 IFS
K120791 · Arthocare Corporation · Dec 2012