MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
Device Facts
| Record ID | K943191 |
|---|---|
| Device Name | MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR |
| Applicant | Boston Scientific Corp |
| Product Code | LQC · Gastroenterology, Urology |
| Decision Date | Aug 29, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4500 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
