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FDA 510(k)

HYPOSERMIC NEEDLES

K-Number: K813545 · 1982-01-12

ApplicantOptical Micro Systems, Inc.
Decision Date1982-01-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPOSERMIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813545. 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 HYPOSERMIC NEEDLES?

HYPOSERMIC NEEDLES is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K813545.

When did HYPOSERMIC NEEDLES receive FDA 510(k) clearance?

HYPOSERMIC NEEDLES received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813545.

Who is the listed applicant for HYPOSERMIC NEEDLES?

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

What is the FDA product code for HYPOSERMIC NEEDLES?

The FDA product code for HYPOSERMIC NEEDLES is FMI.

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Other records listing Optical Micro Systems, 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.

K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935226I/V POLEK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE

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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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