EZO · Urethrotome
Gastroenterology, Urology · 21 CFR 876.4770 · Class 2
Overview
| Product Code | EZO |
|---|---|
| Device Name | Urethrotome |
| Regulation | 21 CFR 876.4770 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000905 | URETHROTOME 8667.XXX AND 8670.XXX | Richard Wolf Medical Instruments Corp. | May 12, 2000 | SESE |
| K950719 | OES UROLOGY | Olympus America, Inc. | Dec 11, 1996 | SESE |
| K945686 | KARL STORZ KNIVES, CURETTES | KARL STORZ Endoscopy-America, Inc. | Feb 13, 1995 | SESE |
| K934730 | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES | KARL STORZ Endoscopy-America, Inc. | Jan 11, 1994 | SESE |
| K904939 | FLEXIBLE AND RIGID URETEROTOME SYSTEM | Olympus Corp. | Jan 7, 1992 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 2 clearances
- Olympus America, Inc. — 1 clearance
- Olympus Corp. — 1 clearance
- Richard Wolf Medical Instruments Corp. — 1 clearance
