F88 0503388008
F88 0503388008 is an invasive medical device leak tester (FDA Class II; FDA product code FGB, Ureteroscope And Accessories, Flexible/Rigid) made by Sg Endoscopy Pte, Ltd., cleared under FDA 510(k) K243894 on 2 May 2025 and listed in FDA GUDID since 30 Jun 2025 (UDI-DI 08881300750077), 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 | Number08881300750077 | Date30 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243894 | Date2 May 2025 | StatusActive |
Official records
- AccessGUDID record 08881300750077
- FDA 510(k) database K243894
Across registries
- FDA 510(k) K243894 decided 2 May 2025 Active
- FDA GUDID UDI-DI 08881300750077 listed 30 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K243894
- Listed FDA GUDID 08881300750077
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- F88
- Generic name
- Invasive medical device leak tester, mechanical
- Model / Ref / Catalog
- 0503388008
- Primary DI / UDI-DI
- 08881300750077
- 510(k) Number
- FDA product code
- FGB
- GMDN term
- Invasive medical device leak tester, mechanical
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Invasive medical device leak tester, mechanical.