BIOPSY MEDIUM, MODEL REF 1062
FDA 510(k) clearance K060983 · decided 2006-07-28
Clearance details
- K-number
- K060983
- Device name
- BIOPSY MEDIUM, MODEL REF 1062
- Applicant
- Medicult A/S
- Decision
- Substantially Equivalent
- Date received
- 2006-04-10
- Decision date
- 2006-07-28
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage st recall (Z-1044-2023) | CooperSurgical, Inc. | 2023-01-31 |