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510(k) K820431

E.R.C.P. CANNULAS by American Endoscopy, Inc. — Product Code ODD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
February 17, 1982
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 American Endoscopy, Inc.

  • K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
  • K841384 — PROXIMA 1 PH MONITOR (July 19, 1984)
  • K833491 — ENDO BITE BLOCK (April 25, 1984)
  • K840818 — BIOPSY FORCEPS (April 13, 1984)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
  • K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
  • K821818 — RETRIEVAL BALLOONS (September 24, 1982)
  • K821819 — PIGTAIL STENTS (August 20, 1982)
  • K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)

Other clearances for product code ODD

  • K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single (May 27, 2025)
  • 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)