Rongeur, Cystoscopic, Hot
A hot cystoscopic rongeur is an electrically heated endoscopic cutting instrument used during cystoscopy to remove or debride tissue within the bladder or urethra using a combination of mechanical biting force and thermal energy for tissue destruction and hemostasis. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. Product code KDO is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology medical specialty. No additional special flags apply to this device.
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Basic Information
- Product Code
- KDO
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914934 | HAND PACK | Jan 21, 1993 | Unknown | Westmark Hospital Supplies |