Urethral Electrode Sheath
FDA 510(k) K915219 · Applied Urology, Inc.
510(k) numberK915219
Submission
- Device name
- Urethral Electrode Sheath
- Applicant
- Applied Urology, Inc.
Launa Hills, CA, US - Received
- November 20, 1991
- Decision date
- July 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K920695 | Ureteral StentFAD · Traditional | 09/23/1992SE |
| K912093 | Disposable Aspiration Irrigation SystemHET · Traditional | 04/24/1992SE |
| K920030 | Sureseal Endoscopic ValveODC · Traditional | 03/18/1992SE |
| K912656 | Endoscopic ElectrodeGEI · Traditional | 09/16/1991SE |
| K912903 | Percutaneous Retractor KitGCJ · Traditional | 08/16/1991SE |
| K905731 | Flexible Endoscopic ElectrodeFAS · Traditional | 01/31/1991SE |
| K903994 | Ureteropyelogram Cath for Retrograde Dye InjectionFGF · Traditional | 10/19/1990SE |
| K901214 | Rigid UreteroscopeFGB · Traditional | 06/01/1990SE |
Questions and answers
When was Urethral Electrode Sheath cleared by the FDA?
Urethral Electrode Sheath (K915219) received a 510(k) decision of Substantially Equivalent on July 23, 1992, 246 days after the submission was received.
What is the product code of K915219?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.