4-WIRE (CARSON) STONE EXTRACTOR
Device Facts
| Record ID | K863081 |
|---|---|
| Device Name | 4-WIRE (CARSON) STONE EXTRACTOR |
| Applicant | Cook Urological, Inc. |
| Product Code | FFL · Gastroenterology, Urology |
| Decision Date | Oct 24, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4680 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
