Advanced Medical Solutions (Plymouth), Ltd.: FDA clearances and approvals
Advanced Medical Solutions (Plymouth), Ltd. has 5 FDA 510(k) clearances (first 2012, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time: 175 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 77 |
| 2013 | 2 | 192 |
| 2014 | 1 | 240 |
| 2015 | 1 | 175 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 4 | 4 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Advanced Medical Solutions (Plymouth), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151182 | LiquiBand Exceed | MPN | 2015-10-26 | 175 |
| K133443 | MARATHON NO STING LIQUID SKIN PROTECTANT | KMF | 2014-07-10 | 240 |
| K132243 | BARLE TISSUE ADHESIVE 2 | MPN | 2013-12-20 | 155 |
| K123133 | BARLE TISSUE ADHESIVE | MPN | 2013-05-22 | 230 |
| K122446 | LIQUIDBAND FLOW CONTROL | MPN | 2012-10-26 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Medical Solutions (Plymouth), Ltd..
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 Advanced Medical Solutions (Plymouth), Ltd. have?
Advanced Medical Solutions (Plymouth), Ltd. has 5 FDA 510(k) clearances (first 2012, latest 2015), across 2 product codes in 1 review panel.
How long does FDA take to clear Advanced Medical Solutions (Plymouth), Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Medical Solutions (Plymouth), Ltd.'s cleared 510(k)s is 175 days.
What devices does Advanced Medical Solutions (Plymouth), Ltd. make?
Its most frequent FDA product codes are MPN (Tissue Adhesive For The Topical Approximation Of Skin, 4); KMF (Bandage, Liquid, 1).
Has Advanced Medical Solutions (Plymouth), Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Medical Solutions (Plymouth), Ltd. Related entities may recall under other names.
Next steps
- See all 5 Advanced Medical Solutions (Plymouth), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MPN, Advanced Medical Solutions (Plymouth), Ltd.'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.