Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
FDA 510(k) K150156 · Ranfac, Corp.
510(k) numberK150156
Submission
- Device name
- Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
- Applicant
- Ranfac, Corp.
Avon, MA, US - Received
- January 23, 2015
- Decision date
- October 19, 2015
- 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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| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNW · Special | 06/12/2019SE |
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| K150563 | Marrow Cellution Bone Marrow Aspiration NeedleKNW · Traditional | 05/22/2015SE |
| K140991 | Ranfac Aspiration Needle with Adjustable GuideKNW · Traditional | 09/11/2014SE |
| K131157 | Ranfac Bone Marrow Aspiration NeedleKNW · Traditional | 10/22/2013SE |
| K031344 | Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) NeedleKNW · Traditional | 05/23/2003SE |
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Questions and answers
When was Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel cleared by the FDA?
Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel (K150156) received a 510(k) decision of Substantially Equivalent on October 19, 2015, 269 days after the submission was received.
What is the product code of K150156?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.