Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories

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

510(k) Number

K061646 ↗

FDA Product Code

FBO

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Ktp/532 & Ktp/Yag

  Class II

  FDA 510(k) K913990 Active Cleared 2 Sep 1992

• Ktp/Yag and Ktp/Yag Plus

  Class II

  FDA 510(k) K914518 Active Cleared 2 Apr 1992

• Ktp/532 and Ktp/Yag

  Class II

  FDA 510(k) K913758 Active Cleared 20 Nov 1991

• Ktp/532 Laser

  Class II

  FDA 510(k) K873330 Active Cleared 18 Nov 1987

• Ktp/532 Surgical Laser

  Class II

  FDA 510(k) K884029 Active Cleared 25 Nov 1988

• 800 Series Surgical Laser System and Acccessories

  Class II

  FDA 510(k) K970948 Active Cleared 21 May 1997

See all devices from Laserscope →

• What is the primary function of the Laserscope Guided Delivery Device Cystourethroscope?

  This device is an endoscopic system intended for diagnostic and therapeutic surgical procedures within the lower urinary tract. It provides visualization and manipulation of anatomy, along with capabilities for ablation, biopsy, incision, and resection of tissue.

• What are the key design features of this cystourethroscope?

  The system features a 24 Fr size and a continuous flow outer sheath. This design is intended to clear blood and tissue debris, helping to maintain a clear operative field during procedures.

• What components are included in the device system?

  The device is supplied as part of a system that includes a continuous flow outer sheath, an inner sheath/bridge, and an obturator. It also includes an operative channel for surgical instruments.

• How is the device classified and cleared for use?

  The device is classified as a class II medical device and has FDA 510(k) clearance with product code FBO. The submission was reviewed by the Gastroenterology, Urology advisory committee.