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510(k) K901844

URESIL TRU-CLOSE DRAINAGE BAG by Uresil Corp. — Product Code EXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1990
Date Received
April 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Bile Collecting
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIG (January 4, 2001)
  • K980278 — URESIL VASCU-FLO INFUSION CATHETER (November 20, 1998)
  • K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING (September 10, 1998)
  • K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER (April 24, 1998)
  • K980889 — URESIL NEPHRO-URETERAL STENT (April 8, 1998)
  • K972582 — URESIL GUIDEWIRE (November 21, 1997)
  • K972583 — URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BI (August 29, 1997)

Other clearances for product code EXF

  • K003078 — MERIT DRAINAGE DEPOT (December 11, 2000)
  • K990428 — DRAINAGE BAG (August 12, 1999)
  • K980005 — MANAN D BAG (January 30, 1998)
  • K961986 — MANAN D BAG (March 13, 1997)
  • K963849 — MANAN D BAG (December 13, 1996)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K911129 — MMG BILE BAG (August 7, 1991)
  • K903449 — URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (September 12, 1990)