Adiprep Adipose Transfer System
FDA 510(k) K121005 · Harvest Technologies, Corp.
510(k) numberK121005
Submission
- Device name
- Adiprep Adipose Transfer System
- Applicant
- Harvest Technologies, Corp.
Plymouth, MA, US - Received
- April 3, 2012
- Decision date
- September 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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).
Other 510(k)s with product code MUU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…MUU · Traditional | Millennium Medical Technologies Inc (Dba Cellmyx) | 03/16/2022SE |
| K203800 | SyntrFuge SystemMUU · Traditional | Syntr Health Technologies, Inc. | 07/02/2021SE |
| K202443 | Smart Kit Basic, Smart Kit ProMUU · Traditional | Bsl Co., Ltd. | 03/11/2021SE |
| K193539 | REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional | Lifecell Corporation | 05/28/2020SE |
| K193363 | Dermapose RefreshMUU · Traditional | Puregraft, LLC | 04/14/2020SE |
| K182732 | JTL-250-01MUU · Traditional | Jointechlabs, Inc. | 11/18/2019SE |
| K191564 | Progenikine Concentrating System 25 mL SystemMUU · Traditional | Emcyte Corporation | 11/07/2019SE |
| K190386 | KTA Adipose Treatment KitMUU · Traditional | Stemics S.A.S | 10/10/2019SE |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional | Auragen Aesthetics, LLC | 05/03/2019SE |
| K172717 | Automatic Tissue Processing UnitMUU · Traditional | Bsl Co. | 05/25/2018SE |
More from Bsl Co.
| 510(k) | Device | Decision |
|---|---|---|
| K103340 | SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemJQC · Special | 12/06/2010SE |
| K052925 | SMARTPREP2 Centrifuge SystemJQC · Traditional | 01/04/2006SE |
| K043261 | Harvest Graft Delivery SyringeFMF · Traditional | 03/11/2005SE |
| K020252 | Smartjet Grafting Liquid Applicator, Models Sk/S & LK/2FMF · Traditional | 04/05/2002SE |
| K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft…LYC · Traditional | 07/03/2001SE |
| K000456 | Harvest Technologies Dual Liquid Applicator, Model Sk/S: Harvest Dual Liquid Applicator…FMF · Traditional | 06/01/2000SE |
| K991430 | Smartprep Centrifuge SystemJQC · Traditional | 05/28/1999SE |
| K983022 | Smartcell Processing SystemCAC · Traditional | 04/02/1999SE |
Questions and answers
When was Adiprep Adipose Transfer System cleared by the FDA?
Adiprep Adipose Transfer System (K121005) received a 510(k) decision of Substantially Equivalent on September 21, 2012, 171 days after the submission was received.
What is the product code of K121005?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.