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510(k) K800961

ENEMA CONTAINER DISP. FOR EMEMA ADMIN. by The Healthcare Group Laboratories, Inc. — Product Code FCE

K800961 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "ENEMA CONTAINER DISP. FOR EMEMA ADMIN.". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code FCE (Enema Kit), a Class I device regulated under 21 CFR 876.5210. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources