510(k) K222856
K222856 is an FDA 510(k) premarket notification submitted by Somavac Medical Solutions, Inc. for the device "SOMAVAC 100 Sustained Vacuum System". The FDA issued a decision of Substantially Equivalent on October 19, 2022. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Somavac Medical Solutions, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2022
- Date Received
- September 21, 2022
- Clearance Type
- Special
- 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