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510(k) K252910

Orca Air/Water and Suction Valves by Boston Scientific — Product Code ODC

K252910 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "Orca Air/Water and Suction Valves". The FDA issued a decision of Substantially Equivalent (kit) on October 9, 2025. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Boston Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 9, 2025
Date Received
September 12, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by Boston Scientific

  • K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging C (April 8, 2026)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K250468 — iSLEEVE Introducer Set (March 20, 2025)
  • K242950 — WallFlex Biliary PLUS RX Stent System (December 6, 2024)
  • K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (October 18, 2024)
  • K242507 — OBSIDIO™ Conformable Embolic (October 3, 2024)
  • K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K234002 — ICEfx Cryoablation System (FPRCH8000-02) (March 13, 2024)
  • K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec (November 28, 2023)

Other clearances for product code ODC

  • K252933 — DYNE PORT (June 12, 2026)
  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)

FDA data resources