Home / 510(k) Clearances / K250573

510(k) K250573

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M by Olympus Medical Systems Corp. — Product Code ODD

K250573 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M". The FDA issued a decision of Substantially Equivalent on May 27, 2025. The device falls under product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2025
Date Received
February 26, 2025
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 Olympus Medical Systems Corp.

  • K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 (July 1, 2026)
  • K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX (May 21, 2026)
  • K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOS (April 23, 2026)
  • K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
  • K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315) (February 22, 2026)
  • K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)

Other clearances for product code ODD

  • K202583 — BioShield biopsy valve EUS - Linear (November 6, 2020)
  • 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