Ureteropyelogram Cath for Retrograde Dye Injection
FDA 510(k) K903994 · Applied Urology, Inc.
510(k) numberK903994
Submission
- Device name
- Ureteropyelogram Cath for Retrograde Dye Injection
- Applicant
- Applied Urology, Inc.
Launa Hills, CA, US - Received
- August 29, 1990
- Decision date
- October 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FGF – Catheter, Ureteral Disposable (X-Ray)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
More from Applied Urology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921838 | Acucise Ureteral Cutting CatheterEYB · Traditional | 02/26/1993SE |
| K925282 | Urological Catheter and AccessoriesFAD · Traditional | 01/13/1993SE |
| K920695 | Ureteral StentFAD · Traditional | 09/23/1992SE |
| K915219 | Urethral Electrode SheathFAS · Traditional | 07/23/1992SE |
| 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 |
| K901214 | Rigid UreteroscopeFGB · Traditional | 06/01/1990SE |
Questions and answers
When was Ureteropyelogram Cath for Retrograde Dye Injection cleared by the FDA?
Ureteropyelogram Cath for Retrograde Dye Injection (K903994) received a 510(k) decision of Substantially Equivalent on October 19, 1990, 51 days after the submission was received.
What is the product code of K903994?
The FDA product code is FGF – Catheter, Ureteral Disposable (X-Ray), a Class II (moderate risk) device regulated under 21 CFR 876.5130.