HER OPTION CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S037 · decided 2011-11-03
Approval details
- PMA number
- P000032
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2011-10-03
- Decision date
- 2011-11-03
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A MANUFACTURING SITES LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNECTICUT AND LONE STAR MEDICAL PRODUCTS IN STAFFORD, TEXAS.
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 |