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FDA 510(k)

PENTAX Medical Gas/Water Feeding Valve OE-B14

K-Number: K232249 · 2023-12-01

ApplicantPentax of America, Inc.
Decision Date2023-12-01
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Gas/Water Feeding Valve OE-B14 is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K232249. 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 PENTAX Medical Gas/Water Feeding Valve OE-B14?

PENTAX Medical Gas/Water Feeding Valve OE-B14 is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Pentax of America, Inc.. The 510(k) number is K232249.

When did PENTAX Medical Gas/Water Feeding Valve OE-B14 receive FDA 510(k) clearance?

PENTAX Medical Gas/Water Feeding Valve OE-B14 received FDA 510(k) clearance on 2023-12-01, under 510(k) number K232249.

Who is the listed applicant for PENTAX Medical Gas/Water Feeding Valve OE-B14?

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

What is the FDA product code for PENTAX Medical Gas/Water Feeding Valve OE-B14?

The FDA product code for PENTAX Medical Gas/Water Feeding Valve OE-B14 is ODC.

Other records listing Pentax of America, 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.

K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)K251127PENTAX Medical Video Processor (EPK-i8020c)K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

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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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