ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
FDA 510(k) clearance K153267 · decided 2016-07-22
Clearance details
- K-number
- K153267
- Device name
- ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
- Applicant
- Origio A/S
- Decision
- Substantially Equivalent
- Date received
- 2015-11-12
- Decision date
- 2016-07-22
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Måløv, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Pa recall (Z-3296-2024) | CooperSurgical, Inc. | 2024-09-26 |
| Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. recall (Z-3297-2024) | CooperSurgical, Inc. | 2024-09-26 |
| Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. recall (Z-3298-2024) | CooperSurgical, Inc. | 2024-09-26 |