Laser Ureteral Catheter
510(k) K181431
Laser Ureteral Catheter is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Cook Incorporated, cleared under FDA 510(k) K181431 on 30 Jul 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181431 | Date30 Jul 2018 | StatusActive |
Official records
- FDA 510(k) database K181431
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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