510(k) K223373
K223373 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery , Ltd. for the device "Enivo". The FDA issued a decision of Substantially Equivalent on Apr 7, 2023. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Aroa Biosurgery , Ltd. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2023
- Date Received
- Nov 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
- 510(k)