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510(k) K932055

PERCUPUMP II by E-Z-Em, Inc. — Product Code FIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
April 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion Or Syringe, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by E-Z-Em, Inc.

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  • 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 FIH

  • K935461 — VECTOR AMBULATORY DRUG DELIVERY SYSTEM (April 28, 1994)
  • K931113 — CADD-TPN(TM) AMBULATORY INFUSION SYSTEM (April 28, 1994)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)
  • K881707 — INTROCULAR FLUID INJECTOR (October 21, 1988)