510(k) K223353
K223353 is an FDA 510(k) premarket notification submitted by Pikdare Spa for the device "DropSafeTM SicuraTM". The FDA issued a decision of Substantially Equivalent on Dec 2, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Pikdare Spa has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 2022
- Date Received
- Nov 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)