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510(k) K884709

ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) by Primrose Medical, Inc. — Product Code ODD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
November 8, 1988
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 Primrose Medical, Inc.

  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884715 — ACHELASIA BALLOON DIALATOR (September 29, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881976 — CATHETER, INTRAVASCULAR (August 4, 1988)
  • K881977 — PRESSURE INFUSOR (July 29, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)
  • K881978 — ENTERAL FEEDING TUBES (July 13, 1988)

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)