Mara Water Vapor Ablation System
FDA premarket approval P160047/S028 · decided 2023-01-19
Approval details
- PMA number
- P160047
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mara Water Vapor Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2022-12-21
- Decision date
- 2023-01-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Change to the manufacturer and manufacturing of the Sleeve Cartridge Sub-Assembly, Outflow Tube Sub-Assembly, and Syringe Sub-Assembly to reduce manufacturing yield loss.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Fetal Pillow (K243799) | CooperSurgical, Inc. | 2025-08-29 |
| CooperSurgical Milex® Pessaries (K250438) | CooperSurgical, Inc. | 2025-04-11 |
| ALLY II Uterine Positioning System™ (UPS) (K223064) | CooperSurgical, Inc. | 2022-10-28 |
| Advincula Delineator Uterine Manipulator (K201086) | CooperSurgical, Inc. | 2020-05-21 |
| Endosee System (K200038) | CooperSurgical, Inc. | 2020-02-05 |
| G210 InviCell Plus with SignipHy pH monitoring (K191020) | CooperSurgical, Inc. | 2020-01-14 |
| Wallace Dual Lumen Oocyte Recovery System (K191291) | CooperSurgical, Inc. | 2019-06-12 |
| Endosee System (K190639) | CooperSurgical, Inc. | 2019-05-15 |