Orca Air/Water and Suction Valves— 510(k) K252910

Unknown

Boston Scientific

FDA 510(k) clearance K252910 for Orca Air/Water and Suction Valves, Unknown on 2025-10-09. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant: Boston Scientific
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-12
Decision date: 2025-10-09
Decision: Unknown
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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K250732 — Disposable Endoscopy Valve Set2025-06-20
K241842 — Luer-Split MAJ-20922025-03-19

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Recalls naming K252910

K-number listed on FDA's recall record

Z-2413-2026 — Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.Class II·Ongoing·Boston Scientific Corporation·20260512

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K252910.

Data sourced from openFDA. This site is unofficial and independent of the FDA.