WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
FDA 510(k) clearance K990349 · decided 1999-07-26
Clearance details
- K-number
- K990349
- Device name
- WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-05
- Decision date
- 1999-07-26
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shelton, CT, US
- 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 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |