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FDA 510(k)

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

K-Number: K040837 · 2004-06-17

ApplicantMedicel AG
Decision Date2004-06-17
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Medicel AG. It received FDA 510(k) clearance on 2004-06-17 under 510(k) number K040837. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE?

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is Medicel AG. The 510(k) number is K040837.

When did MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE receive FDA 510(k) clearance?

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE received FDA 510(k) clearance on 2004-06-17, under 510(k) number K040837.

Who is the listed applicant for MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE?

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

What is the FDA product code for MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE?

The FDA product code for MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE is MSS.

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 Medicel AG 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.

K252540ACCUJECT Injector Set 2.1-1P (LP604590)K231106Accuject Refra Injector AR2900K101134VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430K092023NAVIJECT SUB2-1P, MODEL: LP604430K070669IOL INJECTOR SET

Related Devices (Code: MSS)

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.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

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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