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510(k) K840839

MMG FOLEY CATHETER by Medical Technologies of Georgia — Product Code KOD

K840839 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia for the device "MMG FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Medical Technologies of Georgia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medical Technologies of Georgia

  • K080878 — MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WIT (July 17, 2008)
  • K973120 — READYCATH CATHETER (February 25, 1998)
  • K952392 — MLI SET (August 7, 1995)
  • K911129 — MMG BILE BAG (August 7, 1991)
  • K873136 — MMG CATH-N-PLACE (September 9, 1987)
  • K871949 — MMG DELEE SUCTION CATHETER W/MUCOUS TRAP (June 15, 1987)
  • K854821 — MMG EXTERNAL FEMALE CATHETERS (April 24, 1986)
  • K854660 — THE MMG ENTERAL FEEDING ADMINISTRATION SET (January 21, 1986)
  • K840897 — OXYGEN TUBING (March 16, 1984)
  • K821853 — U-100 BAG (July 22, 1982)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)

FDA data resources