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510(k) K880895

URESIL WOUND DRAIN TROCAR by Uresil Corp. — Product Code GBS

K880895 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL WOUND DRAIN TROCAR". The FDA issued a decision of Substantially Equivalent on March 14, 1988. The device falls under product code GBS (Catheter, Ventricular, 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
March 14, 1988
Date Received
March 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, 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 GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)
  • K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (September 29, 1986)

FDA data resources