Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2025-10-09 under approval 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. It is manufactured by Boston Scientific. The 510(k) number is K252910.

When was Orca Air/Water and Suction Valves approved by the FDA?

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

What company makes Orca Air/Water and Suction Valves?

Orca Air/Water and Suction Valves is manufactured by Boston Scientific.

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.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING NCT04200937 IT Matters: The Erectile Restoration Registry ENROLLING_BY_INVITATION NCT06982235 Stone and Laser Therapies Post-Market Study (SALT) RECRUITING NCT01719055 RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain RECRUITING

Other Devices by Boston Scientific

K160751Symphion Endoscope and Symphion Cervical Sheath DEN150040WallFlex Biliary RX Fully Covered Stent System RMV K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle K180068ORISE Gel K180864WATCHMAN TruSeal Access System

View all 43 devices →

Related Devices (Code: ODC)

K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. K162142Accessory Irrigation AdapterWilson-Cook Medical, Inc. K181712San Antonio StopcockCook Incorporated K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated K192258Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd. K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, 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.

↑