Surgitek Flexible Ureteroscope SU-7 & SU-9

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

510(k) Number

K880801 ↗

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

• Surgitek Articulating Ureteroscope Model SU-11

  Class II

  FDA 510(k) K880802 Active Cleared 26 May 1988

• Percutaneous Nephrostomy Catheter

  Unclassified

  FDA 510(k) K833008 Active Cleared 19 Oct 1983

• 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 Flexible Ureteroscope SU-7 & SU-9 used for?

  It is used for visual examination and treatment within the urinary tract during gastroenterology and urology procedures, allowing healthcare professionals to view and access the urinary system for diagnostic and therapeutic purposes.

• Is the SURGITEK Flexible Ureteroscope SU-7 & SU-9 reusable or single-use?

  It is supplied as a reusable device, meaning it is designed to be cleaned, sterilized, and used multiple times following appropriate reprocessing protocols for clinical safety.

• What regulatory clearance does the SURGITEK Flexible Ureteroscope SU-7 & SU-9 have?

  It received FDA 510(k) clearance under number K880801 on May 26, 1988, indicating it was found substantially equivalent to a legally marketed predicate device under regulation 876.1500.