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510(k) K041995

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY by Uresil, LLC — Product Code GBO

K041995 is an FDA 510(k) premarket notification submitted by Uresil, LLC for the device "MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY". The FDA issued a decision of Substantially Equivalent on August 19, 2004. The device falls under product code GBO (Catheter, Nephrostomy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Uresil, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2004
Date Received
July 23, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Uresil, LLC

  • 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)
  • 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)
  • K953923 — URESIL INTRODUCING NEEDLE (September 8, 1995)

Other clearances for product code GBO

  • K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKIN (June 13, 2002)
  • K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER (August 12, 1991)
  • K854911 — PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (January 24, 1986)
  • K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (January 24, 1986)
  • K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (January 24, 1986)
  • K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (January 24, 1986)
  • K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (January 24, 1986)
  • K820867 — PERCUTANEOUS NEPHROSTOMY SET (April 13, 1982)
  • K781664 — SILASTIC NEPHROSTOMY SYSTEM (January 22, 1979)
  • K781526 — SILASTIC U-TUBE KIT (September 20, 1978)

FDA data resources