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FDA 510(k)

SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM

K-Number: K022239 · 2002-08-23

ApplicantPraxim
Decision Date2002-08-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Praxim. It received FDA 510(k) clearance on 2002-08-23 under 510(k) number K022239. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM?

SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-23. The listed applicant is Praxim. The 510(k) number is K022239.

When did SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM receive FDA 510(k) clearance?

SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM received FDA 510(k) clearance on 2002-08-23, under 510(k) number K022239.

Who is the listed applicant for SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM?

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

What is the FDA product code for SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM?

The FDA product code for SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM is JAK.

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 Praxim 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.

K081232TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELESK031196SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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