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510(k) K850694

WSP CODE 4310 STRESSCATH by Warne Surgical Products, Ltd. — Product Code FAP

K850694 is an FDA 510(k) premarket notification submitted by Warne Surgical Products, Ltd. for the device "WSP CODE 4310 STRESSCATH". The FDA issued a decision of Substantially Equivalent on May 17, 1985. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Warne Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1985
Date Received
February 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K840703 — SECURE W/30MM DIAM, SHEATH & ADHESIVE (March 22, 1984)

Other clearances for product code FAP

  • K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE (December 13, 2012)
  • K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (February 19, 1998)
  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (August 27, 1996)
  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
  • K931179 — UROLAB SPECTRUM (November 18, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)

FDA data resources