510(k) K881218

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

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