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510(k) K901182

ENEMA BAG SET by Orion Life Systems, Inc. — Product Code FCE

K901182 is an FDA 510(k) premarket notification submitted by Orion Life Systems, Inc. for the device "ENEMA BAG SET". The FDA issued a decision of Substantially Equivalent (kit) on June 28, 1990. The device falls under product code FCE (Enema Kit), a Class I device regulated under 21 CFR 876.5210. Orion Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 28, 1990
Date Received
March 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enema Kit
Device Class
Class I
Regulation Number
876.5210
Review Panel
GU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Orion Life Systems, Inc.

  • K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (January 24, 1995)
  • K943834 — STERILE .9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)

Other clearances for product code FCE

  • K974042 — AMSURE CLEANSING ENEMA SET (December 19, 1997)
  • K931896 — PRO-FLO SYSTEM (August 26, 1993)
  • K922398 — 4 SURE TM ENEMA BAG SET (June 17, 1993)
  • K913620 — ENEMA KIT (November 1, 1991)
  • K904534 — ENEMA BULB (December 21, 1990)
  • K901179 — ENEMA BUCKET SET (June 28, 1990)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
  • K881218 — GENT-L-KARE CLEANSING ENEMA SET (July 28, 1988)
  • K880337 — MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (April 14, 1988)

FDA data resources