HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S030 · decided 2010-01-20
Approval details
- PMA number
- P000032
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2009-11-23
- Decision date
- 2010-01-20
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A CHANGE TO THE REFRIGERANT BLEND USED IN THE GAS MIX COMPRESSOR (GMC) OF THE HER OPTION CONSOLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |