SureTip 3728
SureTip 3728 is a general/multiple surgical laser system beam guide (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Clinicon Corp., cleared under FDA 510(k) K014048 on 11 Feb 2002 and listed in FDA GUDID since 5 May 2021 (UDI-DI 00850013050123), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850013050123 | Date5 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK014048 | Date11 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 00850013050123
- FDA 510(k) database K014048
Across registries
- FDA 510(k) K014048 decided 11 Feb 2002 Active
- FDA GUDID UDI-DI 00850013050123 listed 5 May 2021 Listed
Timeline
- Cleared FDA 510(k) K014048
- Listed FDA GUDID 00850013050123
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SureTip
- Generic name
- General/multiple surgical laser system beam guide, single-use
- Model / reference
- 3728
- Primary DI / UDI-DI
- 00850013050123
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical laser system beam guide, single-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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