Axora Medical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Axora Medical, Inc.” (first 2026, latest 2026), plus 2 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 146 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 146 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Axora Medical, Inc. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | 2 | 0 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
Most recent Axora Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | HIH | 2026-08-18 | 146 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P140013 | PMA | MINERVA ENDOMETRIAL ABLATION SYSTEM | 2015-07-27 |
| P000040 | PMA | HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM | 2001-04-20 |
Recalls
openFDA lists no recalls under a recalling firm named Axora Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Axora Medical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Axora Medical, Inc.” (first 2026, latest 2026), plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Axora Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axora Medical, Inc. is 146 days.
Which FDA product codes appear under Axora Medical, Inc.?
The most frequent FDA product codes under this applicant name are MNB (Device, Thermal Ablation, Endometrial, 2); HIH (Hysteroscope (And Accessories), 1).
Next steps
- See all 1 Axora Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNB, Axora Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.