510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K182275Substantially Equivalent

Seal Single Use Biopsy Valve

Boston Scientific Corporation, Marlboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182275 is the FDA 510(k) clearance record for Seal Single Use Biopsy Valve, a class II device, cleared for Boston Scientific Corporation on under FDA product code OCX (Endoscopic Irrigation/Suction System). FDA's definition for product code OCX reads: "To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K182275.

Clearance record

Decision date
Received
(22 days to decision)
Product code
OCX Endoscopic Irrigation/Suction System
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCX

Trailing 12 months

FDA records hold no clearances under product code OCX in the trailing twelve months.

FDA records show no clearances under product code OCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260