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FDA 510(k)

STICK-GARD SAFETY NEEDLE

K-Number: K890620 · 1989-02-28

ApplicantZiehm International, Inc.
Decision Date1989-02-28
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STICK-GARD SAFETY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 1989-02-28 under 510(k) number K890620. 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 STICK-GARD SAFETY NEEDLE?

STICK-GARD SAFETY NEEDLE is a medical device that received FDA 510(k) clearance on 1989-02-28. The listed applicant is Ziehm International, Inc.. The 510(k) number is K890620.

When did STICK-GARD SAFETY NEEDLE receive FDA 510(k) clearance?

STICK-GARD SAFETY NEEDLE received FDA 510(k) clearance on 1989-02-28, under 510(k) number K890620.

Who is the listed applicant for STICK-GARD SAFETY NEEDLE?

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

What is the FDA product code for STICK-GARD SAFETY NEEDLE?

The FDA product code for STICK-GARD SAFETY 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 Ziehm International, 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.

K011292ZIEHM VISIONK910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTORK902196MODIFIED STICK-GARD SAFETY NEEDLEK894021MOBILE X-RAY UNITK894041PUMP-JECT SYRINGE WITH LUER-LOCKK882133MAMMO M

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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

View on FDA Database →

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

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