510(k) K915219
K915219 is an FDA 510(k) premarket notification submitted by Applied Urology, Inc. for the device "URETHRAL ELECTRODE SHEATH". The FDA issued a decision of Substantially Equivalent on July 23, 1992. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Applied Urology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1992
- Date Received
- November 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical, Active, Urological
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type