21 CFR 876.4680 — Dislodger, Stone, Basket, Ureteral, Metal
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4680
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 2 | 52 | |
| FGO | Dislodger, Stone, Flexible | 2 | 19 | |
| NQT | Dislodger, Stone, Flexible, Ureteral, Reprocessed | 2 | 0 | 3rd Party |
| NQU | Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed | 2 | 0 | 3rd Party |
| NQV | Catheter, Suction, Tracheobronchial, Reprocessed | 1 | 0 | 3rd Party |
| ONJ | Dissolvable Gel For Preventing Ureteral Stone Migration | 2 | 1 |
Special Controls
FFL — Dislodger, Stone, Basket, Ureteral, Metal
*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.
eCFR
FGO — Dislodger, Stone, Flexible
*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.
eCFR
NQT — Dislodger, Stone, Flexible, Ureteral, Reprocessed
*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.
eCFR
NQU — Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
*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.
eCFR
NQV — Catheter, Suction, Tracheobronchial, Reprocessed
*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.
eCFR
ONJ — Dissolvable Gel For Preventing Ureteral Stone Migration
*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.
eCFR
