Agency For Medical Innovations GmbH: FDA clearances and approvals
Agency For Medical Innovations GmbH has 5 FDA 510(k) clearances (first 2010, latest 2021), across 5 product codes in 3 review panels. Median 510(k) review time: 85 days. Since 2017 its median was 79 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 85 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 73 |
| 2019 | 1 | 227 |
| 2020 | 0 | — |
| 2021 | 1 | 79 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Agency For Medical Innovations GmbH's cleared 510(k)s took a median 79 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument Port | 1 | 1 |
Review panels
Most recent Agency For Medical Innovations GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212659 | More-Cell-System | PMU | 2021-11-10 | 79 |
| K182013 | EasyInstruments | GEI | 2019-03-11 | 227 |
| K182664 | FiXcision | KOA | 2018-12-07 | 73 |
| K150718 | Wi-3 HAL-RAR System | FHN | 2015-06-12 | 85 |
| K092821 | TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 | GCJ | 2010-02-01 | 140 |
Recalls
openFDA lists no recalls under a recalling firm named Agency For Medical Innovations GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Agency For Medical Innovations GmbH have?
Agency For Medical Innovations GmbH has 5 FDA 510(k) clearances (first 2010, latest 2021), across 5 product codes in 3 review panels.
How long does FDA take to clear Agency For Medical Innovations GmbH's 510(k)s?
The median time from FDA receipt to decision across Agency For Medical Innovations GmbH's cleared 510(k)s is 85 days. Since 2017: 79 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Agency For Medical Innovations GmbH make?
Its most frequent FDA product codes are FHN (Ligator, Hemorrhoidal, 1); GCJ (Laparoscope, General & Plastic Surgery, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Has Agency For Medical Innovations GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Agency For Medical Innovations GmbH. Related entities may recall under other names.
Next steps
- See all 5 Agency For Medical Innovations GmbH clearances with predicates and recalls
- Run predicate analysis for product code FHN, Agency For Medical Innovations GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.