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FDA 510(k)

SARSTEDT NEEDLE PROTECTOR

K-Number: K003382 · 2001-03-30

ApplicantSarstedt, Inc.
Decision Date2001-03-30
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SARSTEDT NEEDLE PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt, Inc.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K003382. 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 SARSTEDT NEEDLE PROTECTOR?

SARSTEDT NEEDLE PROTECTOR is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Sarstedt, Inc.. The 510(k) number is K003382.

When did SARSTEDT NEEDLE PROTECTOR receive FDA 510(k) clearance?

SARSTEDT NEEDLE PROTECTOR received FDA 510(k) clearance on 2001-03-30, under 510(k) number K003382.

Who is the listed applicant for SARSTEDT NEEDLE PROTECTOR?

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

What is the FDA product code for SARSTEDT NEEDLE PROTECTOR?

The FDA product code for SARSTEDT NEEDLE PROTECTOR 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 Sarstedt, 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.

K051019SAFETY NEEDLEK032150SAFETY-MULTIFLYK031359S-MONOVETTE EDTA K2-GELK024237URINE MONOVETTE BORIC ACIDK913622HEMOPLUS

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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