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510(k) K202583

BioShield biopsy valve EUS - Linear by STERIS Corporation — Product Code ODD

K202583 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "BioShield biopsy valve EUS - Linear". The FDA issued a decision of Substantially Equivalent on November 6, 2020. The device falls under product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula), a Class II device regulated under 21 CFR 876.1500. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2020
Date Received
September 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To identify stones, tumors, or narrowing in the biliary tree.

Other clearances by STERIS Corporation

  • K261055 — AMSCO 700 Steam Sterilizer (June 24, 2026)
  • K260766 — Celerity 5 HP Biological Indicator (LCB052) (April 8, 2026)
  • K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 end (April 8, 2026)
  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (May 2, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)

Other clearances for product code ODD

  • K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single (May 27, 2025)
  • K171989 — Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon An (March 20, 2018)
  • K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (March 19, 2007)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)
  • K010993 — ALIEN RX MICRO CANNULA, MODEL 4530 (April 30, 2001)
  • K973205 — WILSON-COOK STRICTURE MEASURING CATHETER (November 24, 1997)
  • K963051 — ERCP CANNULA (March 28, 1997)
  • K953967 — ENDOSCOPIC CATHETER (January 22, 1996)
  • K950700 — BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA (April 27, 1995)
  • K950729 — OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) (March 17, 1995)

FDA data resources