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FDA 510(k)

SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE

K-Number: K012283 · 2001-10-01

ApplicantSafegard Medical Products, Inc.
Decision Date2001-10-01
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Safegard Medical Products, Inc.. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K012283. 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 SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE?

SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Safegard Medical Products, Inc.. The 510(k) number is K012283.

When did SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE receive FDA 510(k) clearance?

SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE received FDA 510(k) clearance on 2001-10-01, under 510(k) number K012283.

Who is the listed applicant for SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE?

The FDA 510(k) record lists Safegard Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE?

The FDA product code for SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE is FMI.

Related Clinical Trials

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.

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Other records listing Safegard Medical Products, Inc. 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.

K012121SECUREGUARD RETRACTABLE SAFETY SYRINGE

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.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.

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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