Cleared Special

K052859 - AQUAMANTYS PUMP GENERATOR SYSTEM

K052859 is an FDA 510(k) clearance for AQUAMANTYS PUMP GENERATOR SYSTEM, manufactured by Tissuelink Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 14-day FDA review.

K052859 · Tissuelink Medical, Inc. · General & Plastic Surgery device
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Oct 2005
Decision
14d
Days
Class 2
Risk

K052859 is an FDA 510(k) clearance for the AQUAMANTYS PUMP GENERATOR SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Tissuelink Medical, Inc. (Dover, US). The FDA issued a Cleared decision on October 25, 2005 after a review of 14 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 Tissuelink Medical, Inc. devices

FDA 510(k) Submission Details - K052859

510(k) Number K052859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date October 25, 2005
Days to Decision 14 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 1528
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K052859.
ARTHROCARE 8000S COBLATOR SURGERY SYSTEM
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ATRICURE TRANSPOLAR SYSTEM
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ALUMA SKIN RENEWAL SYSTEM
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ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185
K052104 · Conmed Corporation · Oct 2005