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FDA 510(k)

Orca Air/Water and Suction Valves

K-Number: K252910 · 2025-10-09

ApplicantBoston Scientific
Decision Date2025-10-09
Product CodeODC
Advisory CommitteeGU
DecisionUnknown

Device Summary

Orca Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K252910. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Orca Air/Water and Suction Valves?

Orca Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Boston Scientific. The 510(k) number is K252910.

When did Orca Air/Water and Suction Valves receive FDA 510(k) clearance?

Orca Air/Water and Suction Valves received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252910.

Who is the listed applicant for Orca Air/Water and Suction Valves?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orca Air/Water and Suction Valves?

The FDA product code for Orca Air/Water and Suction Valves is ODC.

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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.K250949Suction 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 CorporationK250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation

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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