FLEXIBLE AND RIGID URETEROTOME SYSTEM
Device Facts
| Record ID | K904939 |
|---|---|
| Device Name | FLEXIBLE AND RIGID URETEROTOME SYSTEM |
| Applicant | Olympus Corp. |
| Product Code | EZO · Gastroenterology, Urology |
| Decision Date | Jan 7, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
