FGK · Tripsor, Stone, Bladder
Gastroenterology, Urology · 21 CFR 876.4500 · Class 2
Overview
| Product Code | FGK |
|---|---|
| Device Name | Tripsor, Stone, Bladder |
| Regulation | 21 CFR 876.4500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.
Classification Rationale
Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K760273 | LITHOTRITE | V. Mueller O.V. Baxter Healthcare Corp. | Dec 6, 1976 | SESE |
Top Applicants
- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance
