Scissors For Cystoscope
Scissors for Cystoscope are endoscopic surgical instruments designed for use through a cystoscope, enabling the cutting or excision of tissue within the urinary bladder or urethra under endoscopic visualization without the need for open surgery. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGD, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- KGD
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.