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FDA 510(k)

ZENIEVA

K-Number: K073246 · 2008-07-23

ApplicantGorbec Pharmaceutical Services, Inc.
Decision Date2008-07-23
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZENIEVA is the device name listed in this FDA 510(k) record. The listed applicant is Gorbec Pharmaceutical Services, Inc.. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K073246. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENIEVA?

ZENIEVA is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Gorbec Pharmaceutical Services, Inc.. The 510(k) number is K073246.

When did ZENIEVA receive FDA 510(k) clearance?

ZENIEVA received FDA 510(k) clearance on 2008-07-23, under 510(k) number K073246.

Who is the listed applicant for ZENIEVA?

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

What is the FDA product code for ZENIEVA?

The FDA product code for ZENIEVA is NAE.

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 Gorbec Pharmaceutical Services, 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.

K100839BARIREPK082865MODIFICATION TO ZENIEVA

Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical ProductsK971597COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)Coloplast Corp.

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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