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510(k) K950016

CART, MODE NUMBER UDS-CART by Laborie Medical Tech Corp. — Product Code FEN

K950016 is an FDA 510(k) premarket notification submitted by Laborie Medical Tech Corp. for the device "CART, MODE NUMBER UDS-CART". The FDA issued a decision of Substantially Equivalent on March 30, 1995. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Laborie Medical Tech Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1995
Date Received
January 3, 1995
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 Laborie Medical Tech Corp.

  • K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (November 29, 1999)
  • K990041 — UROSTYM BIOFEEDBACK AND STIMULATION PROBES (August 5, 1999)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K963064 — ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (June 5, 1997)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)

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