ALLY UPS
FDA 510(k) clearance K141523 · decided 2014-11-25
Clearance details
- K-number
- K141523
- Device name
- ALLY UPS
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-09
- Decision date
- 2014-11-25
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch CooperSurgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FemVue® Controlled Saline-Air Device (FSA-300) (K253403) | Femasys, Inc. | 2025-12-15 |
| RELIEEV HSG Catheter (HSG7FA1) (K252260) | Li Medical Corporation , Ltd. | 2025-11-26 |
| FemVue MINI Saline-Air Device (K242002) | Femasys, Inc. | 2024-11-22 |
| RELIEEV Uterine Manipulator Injector (CUMI 5.0) (K240364) | Li Medical Corporation , Ltd. | 2024-10-16 |
| FemChec Controlled Saline-Air Device (FCD-250) (K241693) | Femasys, Inc. | 2024-09-06 |
| Rejoni Intrauterine Catheter (K222798) | Rejoni, Inc. | 2022-12-16 |
| ALLY II Uterine Positioning System™ (UPS) (K223064) | CooperSurgical, Inc. | 2022-10-28 |
| Uterine ElevatOR PRO with OccludOR Balloon (K220202) | The O R Company Pty, Ltd. | 2022-03-31 |
| DUMI ManipulatOR (K212505) | The O R Company Pty, Ltd. | 2022-01-10 |
| Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (K181770) | Cook Incorporated | 2019-03-29 |
| Margolin HSG Cannula, Goldstein Sonohysterography Catheter (K180300) | Cook Incorporated | 2018-10-26 |
| Cook Silicone Balloon HSG Catheter (K180291) | Cook Incorporated | 2018-10-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holdin recall (Z-1727-2015) | CooperSurgical, Inc. | 2015-06-08 |
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 |