Laparoscopic Bone Anchored Urethropexy Instrument Tray

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963076 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Control Syringe

  Class II

  FDA 510(k) K960882 Active Cleared 8 Jul 1996

• Laparotomy Bladder Neck Suspension Kit with Bone Anchors

  Class II

  FDA 510(k) K971796 Active Cleared 12 Aug 1997

• Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension

  Class II

  FDA 510(k) K971791 Active Cleared 30 Jul 1997

• Carter-Thomason Needle-Point Suture Passer Instrument Set Open recall

  Class II

  FDA 510(k) K980123 Active Cleared 9 Mar 1998

• Laparoscopic Bladder Neck Suspension Kit

  Class II

  FDA 510(k) K971797 Active Cleared 22 Jul 1997

• External Stability Pad

  Class II

  FDA 510(k) K932979 Active Cleared 2 Nov 1993

See all devices from Louisville Laboratories, Inc. →

• What is the Laparoscopic Bone Anchored Urethropexy Instrument Tray used for?

  This instrument tray is designed for use in laparoscopic procedures to perform urethropexy, a surgical technique aimed at supporting the urethra and bladder neck. It uses bone anchors fixed to pelvic bone structures to treat stress urinary incontinence, a condition where involuntary leakage of urine occurs during physical exertion or activities like coughing or sneezing. The tray provides the specialized tools required for precise placement and secure fixation of these anchors.

• How is the Laparoscopic Bone Anchored Urethropexy Instrument Tray supplied and intended for use?

  The tray is supplied as a complete set of reusable instruments enclosed within a sterile barrier, ensuring sterility for single-use in surgical settings. It is intended exclusively for use in laparoscopic procedures by trained surgeons, adhering to standard sterile surgical protocols. The sterile packaging ensures the instruments remain uncontaminated until use, minimizing infection risks during the procedure.

• Is the instrument tray reusable or single-use?

  The instruments within the tray are reusable, but the sterile barrier packaging is designed for single-use only. This means the instruments themselves can be cleaned, sterilized, and reused for subsequent procedures, provided they are handled and stored according to standard surgical instrument protocols. The sterile barrier, however, is intended to be opened only once and discarded after use to maintain sterility.

• What storage and handling guidelines should be followed for this instrument tray?

  To maintain sterility and functionality, the instrument tray must be stored and handled according to standard surgical instrument protocols. This includes keeping the sterile barrier packaging intact until immediately before use, storing the tray in a clean, dry environment protected from dust, moisture, and contamination, and following manufacturer-recommended cleaning and sterilization procedures for the reusable instruments. Proper storage ensures the instruments remain safe and effective for future procedures.

• Does this instrument tray have any specific regulatory approvals or pathways?

  The Laparoscopic Bone Anchored Urethropexy Instrument Tray has received FDA 510(k) clearance under the Traditional review pathway, with clearance number K963076. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. The device is classified under the Obstetrics/Gynecology category and regulated under the HET product code.