ThermaClear 502500001
ThermaClear 502500001 is a hysteroscopic irrigation/insufflation system (FDA Class II) made by Stryker Corp., cleared under FDA 510(k) K210628 on 4 Nov 2021 and listed in FDA GUDID since 4 Apr 2025 (UDI-DI 07613327626391), 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 | Number07613327626391 | Date4 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210628 | Date4 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 07613327626391
- FDA 510(k) database K210628
Across registries
- FDA 510(k) K210628 decided 4 Nov 2021 Active
- FDA GUDID UDI-DI 07613327626391 listed 4 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K210628
- Listed FDA GUDID 07613327626391
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ThermaClear
- Generic name
- Hysteroscopic irrigation/insufflation system
- Model / Ref / Catalog
- 502500001
- Primary DI / UDI-DI
- 07613327626391
- 510(k) Number
- FDA product code
- HIG, LGZ
- GMDN term
- Hysteroscopic irrigation/insufflation system
- Device class
- Class II
- Regulation number
- 884.1700, 880.5725
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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- DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE by Dexide, Inc.
- THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR by Karl Storz Endoscopy-America, Inc.