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510(k) K913620

ENEMA KIT by York County Blind Center — Product Code FCE

K913620 is an FDA 510(k) premarket notification submitted by York County Blind Center for the device "ENEMA KIT". The FDA issued a decision of Substantially Equivalent (kit) on November 1, 1991. The device falls under product code FCE (Enema Kit), a Class I device regulated under 21 CFR 876.5210.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 1, 1991
Date Received
August 13, 1991
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 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)
  • K904534 — ENEMA BULB (December 21, 1990)
  • K901179 — ENEMA BUCKET SET (June 28, 1990)
  • K901182 — ENEMA BAG 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