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FDA 510(k)

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304

K-Number: K102409 · 2010-11-04

ApplicantByrne Medical, Inc.
Decision Date2010-11-04
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 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 2010-11-04 under 510(k) number K102409. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304?

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 is a medical device that received FDA 510(k) clearance on 2010-11-04. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K102409.

When did DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 receive FDA 510(k) clearance?

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 received FDA 510(k) clearance on 2010-11-04, under 510(k) number K102409.

Who is the listed applicant for DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304?

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 DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304?

The FDA product code for DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 is ODC.

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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 100305K093665ENDO SMARTCAPK092090ERBELIFT HAND PUMP AND FLEXIBLE PROBE

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Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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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