SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
FDA 510(k) clearance K052530 · decided 2005-11-18
Clearance details
- K-number
- K052530
- Device name
- SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
- Applicant
- Galil Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-14
- Decision date
- 2005-11-18
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.