Hydrasolve Lipoplasty System

FDA 510(k) K130152 · Andrew Technologies, LLC

Substantially Equivalent

510(k) numberK130152

Submission

Device name
Hydrasolve Lipoplasty System
Applicant
Andrew Technologies, LLC
Haddonfield, NJ, US
Received
January 22, 2013
Decision date
April 18, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUU – System, Suction, Lipoplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5040
Specialty
General, Plastic Surgery

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

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More from Bsl Co.

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K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…QPB · Special 12/13/2012SE
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Questions and answers

When was Hydrasolve Lipoplasty System cleared by the FDA?

Hydrasolve Lipoplasty System (K130152) received a 510(k) decision of Substantially Equivalent on April 18, 2013, 86 days after the submission was received.

What is the product code of K130152?

The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.