Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia,

FDA 510(k) K121218 · Andrew Technologies, LLC

Substantially Equivalent

510(k) numberK121218

Submission

Device name
Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia,
Applicant
Andrew Technologies, LLC
Haddonfield, NJ, US
Received
April 23, 2012
Decision date
December 13, 2012
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

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Questions and answers

When was Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia, cleared by the FDA?

Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia, (K121218) received a 510(k) decision of Substantially Equivalent on December 13, 2012, 234 days after the submission was received.

What is the product code of K121218?

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