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)

ENDOGATOR

K-Number: K092429 · 2009-11-19

ApplicantByrne Medical, Inc.
Decision Date2009-11-19
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Byrne Medical, Inc.. It received FDA 510(k) clearance on 2009-11-19 under 510(k) number K092429. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOGATOR?

ENDOGATOR is a medical device that received FDA 510(k) clearance on 2009-11-19. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K092429.

When did ENDOGATOR receive FDA 510(k) clearance?

ENDOGATOR received FDA 510(k) clearance on 2009-11-19, under 510(k) number K092429.

Who is the listed applicant for ENDOGATOR?

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

What is the FDA product code for ENDOGATOR?

The FDA product code for ENDOGATOR is FEQ.

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 Byrne Medical, 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.

K113310ENDOGATER AVANTAGE CO2 INSUFFLATORK113119ENDOGATOR ADVANTAGE IRRIGATION PUMPK102855UNIVERSAL IRRIGATION SOLUTION HYBRIDK102581DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305K102409DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304K093665ENDO SMARTCAP

View all 12 devices →

Related Devices (Code: FEQ)

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.

K220395EndoGator Endoscopy Irrigation TubingSTERIS CorporationK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.

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.

↑