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510(k) K881218

GENT-L-KARE CLEANSING ENEMA SET by Geneva Laboratories, Inc. — Product Code FCE

K881218 is an FDA 510(k) premarket notification submitted by Geneva Laboratories, Inc. for the device "GENT-L-KARE CLEANSING ENEMA SET". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code FCE (Enema Kit), a Class I device regulated under 21 CFR 876.5210. Geneva Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
March 22, 1988
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 Geneva Laboratories, Inc.

  • K881217 — GENT-L-KARE STERILE URINARY LEG BAG (July 29, 1988)
  • K881213 — GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (July 28, 1988)
  • K881216 — GENT-L-KARE VAGINAL IRRIGATION SET (June 7, 1988)
  • K861308 — ACCUPAC CUSTOM PACK KERLIX SQUARES (May 2, 1986)
  • K861219 — ACCUPAC CUSTOM SKIN SCRUB KIT (April 15, 1986)
  • K853265 — ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 (August 26, 1985)
  • K843206 — COOK COUNTY HOSPITAL DRESSING CHANGE SET (May 24, 1985)
  • K844255 — GENT-L-KARE STERILE I.V. START KIT (December 19, 1984)
  • K843090 — UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM (December 4, 1984)
  • K830725 — GENT-L-SPEC DISPOS. VAGINAL SPECULUM (April 27, 1983)

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)
  • K901182 — ENEMA BAG SET (June 28, 1990)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
  • K880337 — MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (April 14, 1988)

FDA data resources