Surgitek Graduated Cystoscope (Model GC-16)

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

510(k) Number

K904797 ↗

FDA Product Code

FBO

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hydrophilic Coated Guidewire

  Class II

  FDA 510(k) K926344 Active Cleared 5 Mar 1993

• Grasping Forceps

  Class II

  FDA 510(k) K933261 Active Cleared 11 Jan 1994

• Tissue Expander

  Unclassified

  FDA 510(k) K840464 Active Cleared 12 Mar 1984

• Ureteral Catheter

  Class II

  FDA 510(k) K930483 Active Cleared 16 Jul 1993

• Ureteral Stent

  Class II

  FDA 510(k) K930733 Active Cleared 23 Jul 1993

• Quadra-Coil Ureteral Stent

  Class II

  FDA 510(k) K946296 Active Cleared 6 Mar 1995

See all devices from Surgitek →

• What is the Surgitek Graduated Cystoscope (Model GC-16) used for?

  The Surgitek Graduated Cystoscope (Model GC-16) is a rigid cystourethroscope designed specifically for visual examination of the urinary bladder and urethra. Its key feature is a graduated scale, which allows clinicians to measure bladder capacity or lesion dimensions accurately during diagnostic procedures. This aids in identifying abnormalities, guiding interventions, and ensuring precise assessments in urological settings.

• How is the Surgitek Graduated Cystoscope (Model GC-16) supplied and intended for use?

  This device is supplied as a reusable medical instrument, intended exclusively for clinical use in settings like urology offices, outpatient clinics, or operating rooms. Because it is reusable, it must undergo thorough sterilization between uses to comply with infection control protocols. Proper handling and maintenance are critical to ensure functionality and patient safety.

• Is the Surgitek Graduated Cystoscope (Model GC-16) single-use or reusable?

  The Surgitek Graduated Cystoscope (Model GC-16) is designed as a reusable device. Reusability requires adherence to strict sterilization procedures between patients to prevent cross-contamination. Clinicians must follow manufacturer guidelines for cleaning, disinfection, and sterilization to maintain its performance and ensure patient safety.

• How should the Surgitek Graduated Cystoscope (Model GC-16) be stored?

  Storage of the Surgitek Graduated Cystoscope (Model GC-16) must follow the manufacturer’s guidelines to preserve its functionality and sterility. Proper storage typically involves keeping the device in a clean, dry environment, protected from physical damage, and away from sources of contamination. If the device is stored after sterilization, it should remain in a sealed, sterile packaging until use.

• Does the Surgitek Graduated Cystoscope (Model GC-16) have any specific regulatory approvals?

  The Surgitek Graduated Cystoscope (Model GC-16) holds a 510(k) clearance (K904797) from the FDA, demonstrating substantial equivalence to a predicate device under regulation 876.1500. This clearance confirms that the device meets applicable safety and performance standards for its intended use in urological diagnostics. No explicit MRI safety labeling is provided.