PMA · Approved
Recalled · 2006Her Option (TM) Uterine Cryoblation Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · MNB Device, Thermal Ablation, Endometrial
Approved on Apr 20, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 267-day review. It has been recalled once.
- Decided
- Apr 20, 2001
- Review
- 267 days
- Class
- Class III
- Product code
- MNB
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000032 has 38 supplements since 2001: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 6 |
| 2007 | 2 |
| 2008 | 5 |
| 2009 | 2 |
| 2010 | 6 |
| 2011 | 2 |
| 2013 | 4 |
| 2014 | 1 |
| 2018 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2006 | Not classified | Z-0675-06 | Other | Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MNB devicesMNB Device, Thermal Ablation, Endometrial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNB
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNB
Too few MNB 510(k)s in any year since 2007 to give a median.
Recalls per year · MNB
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNB
250in 2025
MAUDE reports naming product code MNB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | — | 5 | 180 |
| 2008 | 14 | — | 0 | 290 |
| 2009 | 13 | — | 2 | 792 |
| 2010 | 18 | — | 0 | 389 |
| 2011 | 18 | — | 0 | 433 |
| 2012 | 8 | — | 0 | 408 |
| 2013 | 17 | — | 0 | 368 |
| 2014 | 20 | — | 0 | 309 |
| 2015 | 7 | — | 0 | 318 |
| 2016 | 5 | — | 0 | 296 |
| 2017 | 8 | — | 0 | 292 |
| 2018 | 9 | — | 0 | 262 |
| 2019 | 8 | — | 0 | 249 |
| 2020 | 19 | — | 0 | 197 |
| 2021 | 22 | — | 0 | 229 |
| 2022 | 9 | — | 0 | 179 |
| 2023 | 16 | — | 0 | 213 |
| 2024 | 13 | — | 0 | 213 |
| 2025 | 4 | — | 0 | 250 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P000032 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000032: Her Option (TM) Uterine Cryoblation Therapy System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000032
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026