Laparotomy Bladder Neck Suspension Kit

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

510(k) Number

K971801 ↗

FDA Product Code

EZL

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

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 Bone Anchored Urethropexy Instrument Tray

  Class II

  FDA 510(k) K963076 Active Cleared 4 Apr 1997

• Laparoscopic Bladder Neck Suspension Kit

  Class II

  FDA 510(k) K971797 Active Cleared 22 Jul 1997

See all devices from Louisville Laboratories, Inc. →

• What is the Louisville Laparotomy Bladder Neck Suspension Kit used for?

  This kit is designed for laparoscopic bladder neck suspension procedures. It provides mechanical support to the bladder neck and urethra to treat female stress incontinence by suspending these structures surgically. The device is intended to relieve urinary stress incontinence symptoms by maintaining anatomical positioning.

• How is the kit supplied and what are its sterility and reuse specifications?

  The kit is supplied sterile and is intended for single-use only in surgical settings. It adheres to standard sterile surgical instrument protocols, ensuring safety and efficacy for one-time use per procedure. Reuse is not recommended or approved.

• Is this kit suitable for MRI procedures?

  The device data does not specify MRI safety information. If MRI compatibility is required, additional verification or manufacturer documentation should be consulted to ensure safe use in an MRI environment.

• What are the key components included in the kit?

  While the exact components are not detailed in the provided data, the kit is designed for laparoscopic urethropexy and includes all necessary elements for surgical placement of the retention balloon catheter. It is intended to be a comprehensive single-use solution for the specified procedure.

• How should the kit be stored and handled?

  The kit should be stored and handled according to standard sterile surgical instrument protocols. This includes maintaining sterility until use, proper packaging integrity, and adherence to manufacturer guidelines for storage conditions to ensure the device remains effective and safe for its intended single-use application.