Puregraft 850/PURE System
FDA 510(k) K113255 · Cytori Therapeutics, Inc.
510(k) numberK113255
Submission
- Device name
- Puregraft 850/PURE System
- Applicant
- Cytori Therapeutics, Inc.
San Diego, CA, US - Received
- November 3, 2011
- Decision date
- March 7, 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).
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More from Bsl Co.
| 510(k) | Device | Decision |
|---|---|---|
| K132815 | Puregraft 50 SystemMUU · Traditional | 01/24/2014SE |
| K092923 | Cytori Puregraft 250/PURE SystemMUU · Traditional | 01/06/2010SE |
| K072587 | Cytori Aft SystemMUU · Traditional | 12/10/2007SE |
| K063235 | Cytori Lipoplasty System with Celase ReagentQPB · Traditional | 01/24/2007SE |
| K060482 | Cytori Celution Cell Concentration DeviceCAC · Traditional | 09/28/2006SE |
Questions and answers
When was Puregraft 850/PURE System cleared by the FDA?
Puregraft 850/PURE System (K113255) received a 510(k) decision of Substantially Equivalent on March 7, 2012, 125 days after the submission was received.
What is the product code of K113255?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.