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Aquamantys Pump Generator System

by Tissuelink Medical, Inc.

510(k) K052859

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK052859 Date25 Oct 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2892-2011 FDA Unclassified (pre-2012) initiated 18 Jul 2011 on shared 510(k) K052859

    Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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