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FDA 510(k)

NAVIJECT SUB2-1P, MODEL: LP604430

K-Number: K092023 · 2009-07-28

ApplicantMedicel AG
Decision Date2009-07-28
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NAVIJECT SUB2-1P, MODEL: LP604430 is the device name listed in this FDA 510(k) record. The listed applicant is Medicel AG. It received FDA 510(k) clearance on 2009-07-28 under 510(k) number K092023. 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 NAVIJECT SUB2-1P, MODEL: LP604430?

NAVIJECT SUB2-1P, MODEL: LP604430 is a medical device that received FDA 510(k) clearance on 2009-07-28. The listed applicant is Medicel AG. The 510(k) number is K092023.

When did NAVIJECT SUB2-1P, MODEL: LP604430 receive FDA 510(k) clearance?

NAVIJECT SUB2-1P, MODEL: LP604430 received FDA 510(k) clearance on 2009-07-28, under 510(k) number K092023.

Who is the listed applicant for NAVIJECT SUB2-1P, MODEL: LP604430?

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 NAVIJECT SUB2-1P, MODEL: LP604430?

The FDA product code for NAVIJECT SUB2-1P, MODEL: LP604430 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 LP604430K070669IOL INJECTOR SETK040837MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

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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