Abigo Medical AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Abigo Medical AB” (first 1992, latest 2017), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 196 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 193 |
| 2017 | 1 | 117 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abigo Medical AB took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 228 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 4 | 4 |
| MJV | Device, Inflation, Middle Ear | 1 | 1 |
Review panels
Most recent Abigo Medical AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | FRO | 2017-08-21 | 117 |
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | FRO | 2016-07-01 | 193 |
| K100591 | SORBACT | FRO | 2011-01-24 | 328 |
| K063059 | SORBACT WOUND DRESSING | FRO | 2007-04-19 | 196 |
| K920840 | OTOVENT | MJV | 1992-10-05 | 224 |
Recalls
openFDA lists no recalls under a recalling firm named Abigo Medical AB.
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 Abigo Medical AB?
FDA lists 5 510(k) clearances under the applicant name “Abigo Medical AB” (first 1992, latest 2017), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Abigo Medical AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abigo Medical AB is 196 days.
Which FDA product codes appear under Abigo Medical AB?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 4); MJV (Device, Inflation, Middle Ear, 1).
Next steps
- See all 5 Abigo Medical AB clearances with predicates and recalls
- Run predicate analysis for product code FRO, Abigo Medical AB'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.