Home / 510(k) Clearances / K791863

510(k) K791863

MAC LEE ENEMAD by Mac Lee Medical Products — Product Code FCE

K791863 is an FDA 510(k) premarket notification submitted by Mac Lee Medical Products for the device "MAC LEE ENEMAD". The FDA issued a decision of Substantially Equivalent on October 2, 1979. The device falls under product code FCE (Enema Kit), a Class I device regulated under 21 CFR 876.5210. Mac Lee Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1979
Date Received
September 24, 1979
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 Mac Lee Medical Products

  • K872953 — DISPOSABLE I.V. ADMINISTRATION SET (January 6, 1988)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)
  • K870995 — SCALP VEIN SET (July 31, 1987)
  • K864779 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC (December 29, 1986)
  • K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC (December 29, 1986)
  • K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC (December 29, 1986)
  • K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC (December 29, 1986)
  • K864782 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC (December 23, 1986)
  • K864780 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC (December 23, 1986)
  • K864783 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC (December 23, 1986)

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)
  • K881218 — GENT-L-KARE CLEANSING ENEMA SET (July 28, 1988)

FDA data resources