Home / 510(k) Clearances / K912109

510(k) K912109

URESIL GENERAL PURPOSE DRAINAGE CATHETER by Uresil Corp. — Product Code GBO

K912109 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL GENERAL PURPOSE DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on August 12, 1991. The device falls under product code GBO (Catheter, Nephrostomy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Uresil Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1991
Date Received
May 13, 1991
Clearance Type
Traditional
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 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 GBO

  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKIN (June 13, 2002)
  • K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (January 24, 1986)
  • K854911 — PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (January 24, 1986)
  • K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (January 24, 1986)
  • K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (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