Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENDOXANE

K-Number: K971509 · 1997-08-21

ApplicantNovatech SA
Decision Date1997-08-21
Product CodeNWA
Advisory CommitteeSU
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ENDOXANE is the device name listed in this FDA 510(k) record. The listed applicant is Novatech SA. It received FDA 510(k) clearance on 1997-08-21 under 510(k) number K971509. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ENDOXANE?

ENDOXANE is a medical device that received FDA 510(k) clearance on 1997-08-21. The listed applicant is Novatech SA. The 510(k) number is K971509.

When did ENDOXANE receive FDA 510(k) clearance?

ENDOXANE received FDA 510(k) clearance on 1997-08-21, under 510(k) number K971509.

Who is the listed applicant for ENDOXANE?

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

What is the FDA product code for ENDOXANE?

The FDA product code for ENDOXANE is NWA.

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 Novatech SA 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.

K242324DUTAU-NOVATECH®K243126TRACHEOBRONXANE™ DUMON®K170030NOVATECH TALCAIRK151832NOVATECH TALCAIR

Related Devices (Code: NWA)

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.

K261541VisionAir Enhanced Stock StentVisionAir SolutionsK243126TRACHEOBRONXANE™ DUMON®Novatech SAK213969VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair SolutionsK182743Patient-Specific Airway StentNew Cos, Inc.K894380DUMON TRACHEOBRONCHIAL STENTBryan Corp.K873742HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESESHood Laboratories

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.

↑