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510(k) K121005

ADIPREP ADIPOSE TRANSFER SYSTEM by Harvest Technologies, Corp. — Product Code MUU

K121005 is an FDA 510(k) premarket notification submitted by Harvest Technologies, Corp. for the device "ADIPREP ADIPOSE TRANSFER SYSTEM". The FDA issued a decision of Substantially Equivalent on September 21, 2012. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040. Harvest Technologies, Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2012
Date Received
April 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

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).

Other clearances by Harvest Technologies, Corp.

  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K043261 — HARVEST GRAFT DELIVERY SYRINGE (March 11, 2005)
  • K020252 — SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (April 5, 2002)
  • K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRA (July 3, 2001)
  • K000456 — HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID AP (June 1, 2000)
  • K991430 — SMARTPREP CENTRIFUGE SYSTEM (May 28, 1999)
  • K983022 — SMARTCELL PROCESSING SYSTEM (April 2, 1999)

Other clearances for product code MUU

  • K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Bod (March 16, 2022)
  • K203800 — SyntrFuge System (July 2, 2021)
  • K202443 — Smart Kit Basic, Smart Kit Pro (March 11, 2021)
  • K193539 — REVOLVE ENVI 600 Advanced Adipose System (May 28, 2020)
  • K193363 — Dermapose Refresh (April 14, 2020)
  • K182732 — JTL-250-01 (November 18, 2019)
  • K191564 — Progenikine Concentrating System 25 mL System (November 7, 2019)
  • K190386 — KTA Adipose Treatment Kit (October 10, 2019)
  • K190278 — AuraGen 123 Suction Lipoplasty System (A123) (May 3, 2019)
  • K172717 — Automatic Tissue Processing Unit (May 25, 2018)

FDA data resources