WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
FDA 510(k) clearance K033084 · decided 2003-12-19
Clearance details
- K-number
- K033084
- Device name
- WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
- Applicant
- Portex , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-29
- Decision date
- 2003-12-19
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hyth, Kent, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Co recall (Z-1239-2013) | Smiths Medical ASD, Inc. | 2013-05-03 |
| Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 Sur recall (Z-1240-2013) | Smiths Medical ASD, Inc. | 2013-05-03 |
| Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pr recall (Z-1241-2013) | Smiths Medical ASD, Inc. | 2013-05-03 |
| Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro Embr recall (Z-1242-2013) | Smiths Medical ASD, Inc. | 2013-05-03 |
| Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet recall (Z-1243-2013) | Smiths Medical ASD, Inc. | 2013-05-03 |
| Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro Emb recall (Z-1244-2013) | Smiths Medical ASD, Inc. | 2013-05-03 |