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FDA 510(k)

DropSafeTM SicuraTM

K-Number: K223353 · 2022-12-02

ApplicantPikdare Spa
Decision Date2022-12-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DropSafeTM SicuraTM is the device name listed in this FDA 510(k) record. The listed applicant is Pikdare Spa. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K223353. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DropSafeTM SicuraTM?

DropSafeTM SicuraTM is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Pikdare Spa. The 510(k) number is K223353.

When did DropSafeTM SicuraTM receive FDA 510(k) clearance?

DropSafeTM SicuraTM received FDA 510(k) clearance on 2022-12-02, under 510(k) number K223353.

Who is the listed applicant for DropSafeTM SicuraTM?

The FDA 510(k) record lists Pikdare Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DropSafeTM SicuraTM?

The FDA product code for DropSafeTM SicuraTM is FMI.

Other records listing Pikdare Spa as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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