ONJ · Dissolvable Gel For Preventing Ureteral Stone Migration
Gastroenterology, Urology · 21 CFR 876.4680 · Class 2
Overview
| Product Code | ONJ |
|---|---|
| Device Name | Dissolvable Gel For Preventing Ureteral Stone Migration |
| Regulation | 21 CFR 876.4680 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090430 | BACKSTOP AND BACKSTOP INJECTOR | Pluromed, Inc. | Jun 2, 2009 | SESE |
Top Applicants
- Pluromed, Inc. — 1 clearance
