Direct comparison
Cystoscope vs Ureteroscope: Key Differences
Cystoscope vs ureteroscope: which urinary tract area each examines, length, rigid or flexible, and FDA codes FAJ and FGB (21 CFR 876.1500).
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How do Cystoscope, Ureteroscope compare side by side?
The table below compares Cystoscope, Ureteroscope across 10 procurement-relevant dimensions, from part of the urinary tract examined through source.
Side-by-side comparison
| Dimension | Cystoscope | Ureteroscope |
|---|---|---|
| Part of the urinary tract examined | The urethra and bladder. | The ureters and the kidneys. |
| What the scope is for (FDA intended use) | "To examine and perform procedures within the urinary tract." (product code FAJ) | "To perform various diagnostic and therapeutic procedures within the urinary tract." (product code FGB) |
| Basic construction | Eyepiece at one end, a tube in the middle, a lens and light at the other end. | Same basic layout: eyepiece, tube, and a lens and light at the tip. |
| Length and thickness | Shorter and thicker than a ureteroscope. | Longer and thinner than a cystoscope, which lets it reach the ureters and the lining of the kidney. |
| Rigid or flexible | The tube can be rigid or flexible. | The tube can be rigid or flexible. The name alone does not tell you which; the specification does. |
| FDA product code and name | FAJ: Cystoscope and accessories, flexible/rigid. | FGB: Ureteroscope and accessories, flexible/rigid. |
| Regulation and class | 21 CFR 876.1500 (endoscope and accessories); Class 2. | 21 CFR 876.1500 (endoscope and accessories); Class 2. Same regulation as the cystoscope. |
| Reprocessing evidence for reusable flexible versions | FDA lists reprocessing instructions and validation data as expected in the 510(k) for reusable flexible scopes in this code. | Same expectation under this code for reusable flexible scopes. |
| When this is the relevant device | The question concerns the urethra or bladder. | The question concerns the ureters or kidneys. |
| Source | NIDDK, Cystoscopy and Ureteroscopy (read 2026-10-30); FDA product classification database, codes FAJ and FGB (read 2026-10-30); 21 CFR 876.1500 (eCFR, read 2026-10-30). | Same sources. |
Common questions
Common questions about Cystoscope vs Ureteroscope
What is the main difference between a cystoscope and a ureteroscope?
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Where they are used. NIDDK describes a cystoscope as used to look inside the urethra and bladder and a ureteroscope as used to look inside the ureters and kidneys. The ureteroscope is longer and thinner.
Is a ureteroscope always flexible and a cystoscope always rigid?
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No. NIDDK says the tube of these scopes can be rigid or flexible, and FDA's product codes for both are titled "flexible/rigid". The specification of the specific model states which it is.
Are cystoscopes and ureteroscopes regulated differently by FDA?
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They share one regulation, 21 CFR 876.1500, and both product codes (FAJ and FGB) are Class 2. They are separate product codes with different intended-use wording.
Going deeper
