Clearance Summary
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, received FDA 510(k) clearance under submission number K121218, sponsored by Andrew Technologies, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-12-13.
- Submission: K121218
- Applicant / Sponsor: Andrew Technologies, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2012-12-13
Classification & Regulation
This clearance is catalogued under FDA product code QPB and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.