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510(k) K860571

F.M. WEIST,KG (URODYNAMIC SYSTEMS) by F.M. Wiest USA, Inc. — Product Code FAP

K860571 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "F.M. WEIST,KG (URODYNAMIC SYSTEMS)". The FDA issued a decision of Substantially Equivalent on March 18, 1986. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. F.M. Wiest USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1986
Date Received
February 14, 1986
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 F.M. Wiest USA, Inc.

  • K921871 — HYSTEROMAT(TM) 3700 (December 15, 1994)
  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K920575 — MERKUR 4000 (July 23, 1992)
  • K915751 — URETEROMAT 4400 (April 24, 1992)
  • K911844 — HYSTEROFLATOR 1500 (November 21, 1991)
  • K912071 — SPACE(TM) 7500 (July 9, 1991)
  • K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
  • K871181 — ARTHROCOMBI 5003 (September 29, 1987)

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