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FDA 510(k)

ENDO GATOR SYSTEM

K-Number: K031773 · 2003-06-24

ApplicantByrne Medical, Inc.
Decision Date2003-06-24
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO GATOR SYSTEM 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 2003-06-24 under 510(k) number K031773. 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 ENDO GATOR SYSTEM?

ENDO GATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-24. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K031773.

When did ENDO GATOR SYSTEM receive FDA 510(k) clearance?

ENDO GATOR SYSTEM received FDA 510(k) clearance on 2003-06-24, under 510(k) number K031773.

Who is the listed applicant for ENDO GATOR SYSTEM?

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 ENDO GATOR SYSTEM?

The FDA product code for ENDO GATOR SYSTEM is OCX.

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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

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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.

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