Surgitek Articulating Ureteroscope Model SU-11

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

510(k) Number

K880802 ↗

FDA Product Code

FGB

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Surgitek Urinary Diversion Stent

  Class II

  FDA 510(k) K800109 Active Cleared 26 Feb 1980

• Surgitek Percutaneous Arnegrade Silitek

  Class II

  FDA 510(k) K831857 Active Cleared 11 Aug 1983

• Percutaneous Nephrostomy Catheter

  Unclassified

  FDA 510(k) K833008 Active Cleared 19 Oct 1983

• Surgitek Flexible Ureteroscope SU-7 & SU-9

  Class II

  FDA 510(k) K880801 Active Cleared 26 May 1988

• Surgitek Percutaneous Nephrostomy Cath

  Unclassified

  FDA 510(k) K830226 Active Cleared 9 Feb 1983

• Anastomasis Occluder

  Class I

  FDA 510(k) K761328 Active Cleared 1 Feb 1977

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• What is the Surgitek Articulating Ureteroscope Model SU-11 used for?

  The Surgitek Articulating Ureteroscope Model SU-11 is a flexible/rigid device used for medical procedures in urology and gastroenterology fields, providing visualization and access within the urinary tract during diagnostic and therapeutic interventions.

• Is the Surgitek Articulating Ureteroscope Model SU-11 single-use or reusable?

  The device data does not specify whether the Surgitek Articulating Ureteroscope Model SU-11 is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.

• What is the regulatory status of the Surgitek Articulating Ureteroscope Model SU-11?

  The Surgitek Articulating Ureteroscope Model SU-11 received FDA 510(k) clearance on May 26, 1988, with the K880802 number. It is classified as Class II under product code FGB with special controls.

• What are the storage conditions for the Surgitek Articulating Ureteroscope Model SU-11?

  The device data does not provide specific information regarding storage conditions for the Surgitek Articulating Ureteroscope Model SU-11. Storage requirements would typically be detailed in the product's instructions for use provided by the manufacturer.