510(k) K800959

LARGE VOLUME ENEMA CONTAINER DISPOSABLE by The Healthcare Group Laboratories, Inc. — Product Code FCE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 14, 1980
Date Received: April 23, 1980
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 The Healthcare Group Laboratories, Inc.

K850035 — EMPTY SOLUTION TRANSFER CONTAINER (June 7, 1985)
K842170 — EMPTY SOLUTION TRANSFER CONTAINER (October 19, 1984)
K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY (July 23, 1984)
K840742 — RIGHT ATRIAL CATHETER (July 13, 1984)
K830299 — SOLUTION TRANSFER CONTAINER (February 19, 1983)
K822307 — ADHESIVE SPRAY #4050-4060 (September 24, 1982)
K822059 — SHOW'RBAG (July 22, 1982)
K821480 — RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT (June 17, 1982)
K821230 — SOFTIC 49 (May 28, 1982)
K821162 — ADHESIVE REMOVER (May 14, 1982)

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)
K901182 — ENEMA BAG SET (June 28, 1990)
K901179 — ENEMA BUCKET SET (June 28, 1990)
K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
K881218 — GENT-L-KARE CLEANSING ENEMA SET (July 28, 1988)