Cleared Special

K120537 - AQUAMANTYS3 9.5 XL BIPOLAR SEALER

K120537 is the FDA 510(k) clearance for AQUAMANTYS3 9.5 XL BIPOLAR SEALER by Medtronic, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 78-day FDA review.

K120537 · Medtronic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
78d
Days
Class 2
Risk

K120537 is an FDA 510(k) clearance for the AQUAMANTYS3 9.5 XL 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, Inc. (Portsmouth, US). The FDA issued a Cleared decision on May 10, 2012 after a review of 78 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K120537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2012
Decision Date May 10, 2012
Days to Decision 78 days
Submission Type Special
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
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 956
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K120537.
AQUAMANTRYS3 BSC 9.1S
K121290 · Medtronic, Inc. · Jun 2012
CONMED SUREFIT DUAL DISPERSIVE ELECTRODE
K120322 · Conmed Corporation · Jun 2012
MACROLYTE DISPERSIVE ELECTRODE
K120476 · Conmed Corporation · Jun 2012
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
K120095 · Depuy Mitek, A Johnson & Johnson Company · Apr 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · Boston Scientific Corporation · Mar 2012
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN
K113545 · Depuy Mitek, A Johnson & Johnson Company · Feb 2012