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510(k) K021632

GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C by Uresil, L.P. — Product Code GBO

K021632 is an FDA 510(k) premarket notification submitted by Uresil, L.P. for the device "GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code GBO (Catheter, Nephrostomy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
May 17, 2002
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 for product code GBO

  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER (August 12, 1991)
  • K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (January 24, 1986)
  • K854911 — PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (January 24, 1986)
  • K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (January 24, 1986)
  • K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (January 24, 1986)
  • K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (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