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510(k) K922776

FST COUNCIL TIP FOLEY CATHETER by Fiberoptic Sensor Technlogies, Inc. — Product Code FEN

K922776 is an FDA 510(k) premarket notification submitted by Fiberoptic Sensor Technlogies, Inc. for the device "FST COUNCIL TIP FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on July 20, 1993. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Fiberoptic Sensor Technlogies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1993
Date Received
June 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Fiberoptic Sensor Technlogies, Inc.

  • K945753 — FST FIBEROPTIC PRESSURE CONVERTER (May 11, 1995)
  • K950908 — FST CATH-UD, CATHETER (April 7, 1995)
  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR (November 4, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K926088 — FST CATH UD-DUAL DUAL PRESSURE CATHETER (June 18, 1993)
  • K913113 — FST CATH-UD CATHETER, MODIFICATION (October 9, 1991)
  • K913721 — FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (October 8, 1991)
  • K905641 — FST CATH-UD CATHETER (February 19, 1991)
  • K864000 — FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 (January 16, 1987)

Other clearances for product code FEN

  • K212830 — CT3000Pro (December 21, 2021)
  • K082701 — URONIRS, MODEL 2000 (December 18, 2008)
  • K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (March 5, 2008)
  • K001386 — ACCUSET SENSOR, MODEL 2000 (July 17, 2000)
  • K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
  • K983325 — IN-PROBE II URODYNAMIC SYSTEM (November 24, 1998)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)
  • K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (June 3, 1997)
  • K964522 — ELLIPSE 4 (March 21, 1997)
  • K960503 — DANTEC DUET (September 16, 1996)

FDA data resources