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510(k) K821853

U-100 BAG by Medical Technologies of Georgia — Product Code KNX

K821853 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia for the device "U-100 BAG". The FDA issued a decision of Substantially Equivalent on July 22, 1982. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medical Technologies of Georgia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1982
Date Received
June 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
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)
  • K840839 — MMG FOLEY CATHETER (April 17, 1984)
  • K840897 — OXYGEN TUBING (March 16, 1984)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)

FDA data resources