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)

SAFYRE VS AND SAFYRE T

K-Number: K033691 · 2003-12-19

ApplicantPromedon
Decision Date2003-12-19
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFYRE VS AND SAFYRE T is the device name listed in this FDA 510(k) record. The listed applicant is Promedon. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033691. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFYRE VS AND SAFYRE T?

SAFYRE VS AND SAFYRE T is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Promedon. The 510(k) number is K033691.

When did SAFYRE VS AND SAFYRE T receive FDA 510(k) clearance?

SAFYRE VS AND SAFYRE T received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033691.

Who is the listed applicant for SAFYRE VS AND SAFYRE T?

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

What is the FDA product code for SAFYRE VS AND SAFYRE T?

The FDA product code for SAFYRE VS AND SAFYRE T is OTN.

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 Promedon 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.

K020007SAFYRE SLING SYSTEM

Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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.

↑