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510(k) K073552

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY by Laborie Medical Technologies, Corp. — Product Code FEN

K073552 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Corp. for the device "LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY". The FDA issued a decision of Substantially Equivalent on March 5, 2008. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Laborie Medical Technologies, Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2008
Date Received
December 18, 2007
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 Technologies, Corp.

  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • K240007 — Solar Compact (G4-1) (May 6, 2024)
  • K234107 — Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (April 23, 2024)
  • K090830 — LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (July 21, 2009)
  • K082614 — EVOX ELECTRO DIAGNOSTIC DEVICE (March 6, 2009)
  • K081781 — NUWAV (July 9, 2008)
  • K070331 — UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (May 4, 2007)
  • K962009 — UROSTYM (May 20, 1997)
  • K955856 — TEX-AID BLUE (February 16, 1996)
  • K955810 — U-TEX (January 24, 1996)

Other clearances for product code FEN

  • K212830 — CT3000Pro (December 21, 2021)
  • K082701 — URONIRS, MODEL 2000 (December 18, 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)
  • K953734 — LUMAX(MODIFICATION) (January 18, 1996)

FDA data resources