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510(k) K903449

URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET by Uresil Corp. — Product Code EXF

K903449 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code EXF (Bag, Bile Collecting), a Class II device regulated under 21 CFR 876.5010. Uresil Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
July 30, 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

Other clearances by Uresil Corp.

  • K093653 — URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK (February 23, 2010)
  • K053245 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CA (December 20, 2005)
  • 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)
  • K901844 — URESIL TRU-CLOSE DRAINAGE BAG (June 1, 1990)

FDA data resources