Sureseal Endoscopic Valve
FDA 510(k) K920030 · Applied Urology, Inc.
510(k) numberK920030
Submission
- Device name
- Sureseal Endoscopic Valve
- Applicant
- Applied Urology, Inc.
Launa Hills, CA, US - Received
- January 3, 1992
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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| K912093 | Disposable Aspiration Irrigation SystemHET · Traditional | 04/24/1992SE |
| 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 Sureseal Endoscopic Valve cleared by the FDA?
Sureseal Endoscopic Valve (K920030) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 75 days after the submission was received.
What is the product code of K920030?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.