DropSafeTM SicuraTM
FDA 510(k)Class II (US FDA 510(k))
by Pikdare Spa
Identifiers
- 510(k) Number
- K223353 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DropSafe Sicura is a single lumen hypodermic needle. It is designed to function as a medical device for general hospital use.
This device is identified by FDA 510(k) number K223353 and has received FDA 510(k) clearance. It is manufactured by Pikdare Spa and is classified under product code FMI.
Frequently asked questions
What is the intended use of the DropSafe Sicura?
The DropSafe Sicura is a single lumen hypodermic needle intended for general hospital use. It is designed to function as a medical device for standard clinical procedures requiring hypodermic access.
Has this device received regulatory authorization?
Yes, the DropSafe Sicura has received FDA 510(k) clearance. It is identified by the FDA 510(k) number K223353, which confirms its status as substantially equivalent for its intended use.
Who is the manufacturer of this hypodermic needle?
The DropSafe Sicura is manufactured by Pikdare Spa, located in Casnate Con Bernate, Italy. The company is the official applicant for the device's FDA 510(k) clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K223353 FDA 510(k) - DropSafeTM SicuraTM | Pikdare Spa, DropSafeTM SicuraTM 510 (k) K223353 - FDA.report, K223353 · DropSafeTM SicuraTM · DeviceClearance, DropSafeTM SicuraTM — FDA 510 (k) K223353 | MedTracker, MTD Group: An Innovative Safety Needle With Fully Passive ... - BioSpace
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223353 | Class II | Active |
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Manufacturer
- Manufacturer
- Pikdare Spa
Sources (1)
- FDA 510(k) K223353 24 fields · synced Sep 21, 2026