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510(k) K955810

U-TEX by Laborie Medical Technologies, Ltd. — Product Code FHA

K955810 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Ltd. for the device "U-TEX". The FDA issued a decision of Substantially Equivalent on January 24, 1996. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Laborie Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
December 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Penile
Device Class
Class I
Regulation Number
876.5160
Review Panel
GU
Submission Type

Other clearances by Laborie Medical Technologies, Ltd.

  • 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)
  • 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 FHA

  • K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE (July 14, 1998)
  • K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (August 1, 1997)
  • K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (April 2, 1997)
  • K964580 — CAP-AID (IMPROVED) (January 10, 1997)
  • K954959 — CAP-AID (December 6, 1995)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K896160 — WILLIAMS PENILE ANESTHETIC RETAINER (February 16, 1990)
  • K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE (February 8, 1989)
  • K863227 — COOK-VPI CONTINENCE CUFF (February 3, 1987)
  • K780137 — CLAMP, INCONTINENCE, BAUMRUCKER (April 28, 1978)

FDA data resources