21 CFR 876.4500 — Tripsor, Stone, Bladder
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FGK | Tripsor, Stone, Bladder | 2 | 1 | 3rd Party |
| LQC | Lithotriptor, Biliary Mechanical | 2 | 11 |
Special Controls
FGK — Tripsor, Stone, Bladder
*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.
eCFR
LQC — Lithotriptor, Biliary Mechanical
*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.
eCFR
