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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 a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2023-12-01 under approval 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. It is manufactured by Pentax of America, Inc.. The 510(k) number is K232249.

When was PENTAX Medical Gas/Water Feeding Valve OE-B14 approved by the FDA?

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

What company makes PENTAX Medical Gas/Water Feeding Valve OE-B14?

PENTAX Medical Gas/Water Feeding Valve OE-B14 is manufactured by Pentax of America, Inc..

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.

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Related PubMed Literature

PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 39878385 Navigating AAMI ST108 Water Quality Requirements for Safe Processing of Medical Devices. AORN journal (2025)

Other Devices by Pentax of America, Inc.

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Related Devices (Code: ODC)

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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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