Home / 510(k) Clearances / K904299

510(k) K904299

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF by E-Z-Em, Inc. — Product Code FGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1990
Date Received
September 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention, Barium Enema With Bag
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by E-Z-Em, Inc.

  • K071378 — MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES (June 13, 2007)
  • K062449 — EMPOWERMR INJECTOR SYSTEM, MODEL 9730 (April 13, 2007)
  • K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 (November 2, 2006)
  • K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR (December 27, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031571 — EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (June 19, 2003)
  • K030854 — PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 (April 16, 2003)
  • K013219 — PROTOCO2L INSUFFLATOR MODEL 6400 (February 19, 2002)
  • K011160 — E-Z EM PERCUPUMP 2001 CT INJECTOR (May 16, 2001)
  • K974621 — PERCUPUMP II WITH EDA (January 27, 1998)

Other clearances for product code FGD

  • K223890 — NAJA Gastrointestinal Catheter (June 16, 2023)
  • K905026 — DUAL FLEX NON-LATEX (December 18, 1991)
  • K905574 — SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF (January 24, 1991)
  • K884379 — MAGLINTE ENTEROCLYSIS CATHETER (February 28, 1989)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)