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510(k) K924086

NICKI, MODEL NUMBER USD-NK-UP1 by Laborie Medical Technologies, Ltd. — Product Code FAP

K924086 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Ltd. for the device "NICKI, MODEL NUMBER USD-NK-UP1". The FDA issued a decision of Substantially Equivalent on October 20, 1992. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Laborie Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1992
Date Received
August 13, 1992
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 Laborie Medical Technologies, Ltd.

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  • 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)
  • K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (March 5, 2008)
  • K070331 — UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (May 4, 2007)
  • K962009 — UROSTYM (May 20, 1997)
  • K955856 — TEX-AID BLUE (February 16, 1996)

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