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FDA 510(k)

PROCLUDE

K-Number: K002989 · 2000-12-14

ApplicantOrtek Therapeutics, Inc.
Decision Date2000-12-14
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCLUDE is the device name listed in this FDA 510(k) record. The listed applicant is Ortek Therapeutics, Inc.. It received FDA 510(k) clearance on 2000-12-14 under 510(k) number K002989. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCLUDE?

PROCLUDE is a medical device that received FDA 510(k) clearance on 2000-12-14. The listed applicant is Ortek Therapeutics, Inc.. The 510(k) number is K002989.

When did PROCLUDE receive FDA 510(k) clearance?

PROCLUDE received FDA 510(k) clearance on 2000-12-14, under 510(k) number K002989.

Who is the listed applicant for PROCLUDE?

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

What is the FDA product code for PROCLUDE?

The FDA product code for PROCLUDE is EJR.

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 Ortek Therapeutics, 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.

K170822Electronic Caries DetectorK003482PROCLUDE-SENSITIVE

Related Devices (Code: EJR)

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.

K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AK121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.K103114OSSPRAY SYLC CROsspray, Ltd.K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.K101104REMIN PROVoco GmbHK100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, 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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