WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
FDA 510(k) clearance K012068 · decided 2001-08-03
Clearance details
- K-number
- K012068
- Device name
- WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
- Applicant
- Sims Portex , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-02
- Decision date
- 2001-08-03
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- MQE
- Device class
- 2
- Regulation number
- 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hythe, Kent, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, recall (Z-0593-2009) | Irvine Scientific Sales Co Inc | 2008-12-22 |