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 ADVANTAGE IRRIGATION PUMP

K-Number: K113119 · 2012-04-27

ApplicantByrne Medical, Inc.
Decision Date2012-04-27
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOGATOR ADVANTAGE IRRIGATION PUMP 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 2012-04-27 under 510(k) number K113119. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOGATOR ADVANTAGE IRRIGATION PUMP?

ENDOGATOR ADVANTAGE IRRIGATION PUMP is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K113119.

When did ENDOGATOR ADVANTAGE IRRIGATION PUMP receive FDA 510(k) clearance?

ENDOGATOR ADVANTAGE IRRIGATION PUMP received FDA 510(k) clearance on 2012-04-27, under 510(k) number K113119.

Who is the listed applicant for ENDOGATOR ADVANTAGE IRRIGATION PUMP?

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 ADVANTAGE IRRIGATION PUMP?

The FDA product code for ENDOGATOR ADVANTAGE IRRIGATION PUMP is OCX.

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 INSUFFLATORK102855UNIVERSAL IRRIGATION SOLUTION HYBRIDK102581DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305K102409DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304K093665ENDO SMARTCAPK092090ERBELIFT HAND PUMP AND FLEXIBLE PROBE

View all 12 devices →

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, 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.

↑