Tripsor, Stone, Bladder
The Bladder Stone Tripsor is an instrument used to crush or fragment calculi (stones) within the urinary bladder, allowing the fragments to be irrigated and removed. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FGK, regulated under 21 CFR 876.4500, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FGK
- Device Class
- FDA class 2
- Regulation Number
- 876.4500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K760273 | LITHOTRITE | Dec 06, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.