LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
FDA 510(k) K150779 · Microaire Surgical Instruments, LLC
510(k) numberK150779
Submission
- Device name
- LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
- Applicant
- Microaire Surgical Instruments, LLC
Charlottesville, VA, US - Received
- March 25, 2015
- Decision date
- May 22, 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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Questions and answers
When was LipoFilter - Hospital Pack, LipoFilter - Clinic Pack cleared by the FDA?
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack (K150779) received a 510(k) decision of Substantially Equivalent on May 22, 2015, 58 days after the submission was received.
What is the product code of K150779?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.