Urethrotome
The Urethrotome (product code EZO) is a surgical instrument used to incise urethral strictures from within the urethra under endoscopic visualization, restoring normal urinary flow. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.4770 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- EZO
- Device Class
- FDA class 2
- Regulation Number
- 876.4770
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K000905 | URETHROTOME 8667.XXX AND 8670.XXX | May 12, 2000 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K950719 | OES UROLOGY | Dec 11, 1996 | Substantially Equivalent | Olympus America, Inc. |
| K945686 | KARL STORZ KNIVES, CURETTES | Feb 13, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K934730 | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES | Jan 11, 1994 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K904939 | FLEXIBLE AND RIGID URETEROTOME SYSTEM | Jan 07, 1992 | Substantially Equivalent | Olympus Corp. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.