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510(k) K973120

READYCATH CATHETER by Medical Technologies of Georgia — Product Code GBM

K973120 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia for the device "READYCATH CATHETER". The FDA issued a decision of Substantially Equivalent on February 25, 1998. The device falls under product code GBM (Catheter, Urethral), 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
February 25, 1998
Date Received
August 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
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)
  • 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)
  • K840839 — MMG FOLEY CATHETER (April 17, 1984)
  • K840897 — OXYGEN TUBING (March 16, 1984)
  • K821853 — U-100 BAG (July 22, 1982)

Other clearances for product code GBM

  • K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic In (March 5, 2025)
  • K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (June 22, 2022)
  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
  • K200820 — SpeediCath Compact Set (November 13, 2020)
  • K192904 — SpeediCath Compact Set (November 2, 2020)
  • K200142 — SpeediCath Soft (July 30, 2020)
  • K200134 — Jimushi Sterile Urethral Catheter for single use (June 1, 2020)
  • K191512 — LotusCatheter (Lotus No Balloon Catheter) (May 21, 2020)
  • K192577 — Actreen Hi-Lite Intermittent Urinary Catheters (May 7, 2020)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)

FDA data resources