Adhezion Biomedical, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Adhezion Biomedical, LLC” (first 2008, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 156 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 | 3 | 125 |
| 2014 | 3 | 101 |
| 2015 | 1 | 107 |
| 2016 | 1 | 211 |
| 2017 | 1 | 220 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 187 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Adhezion Biomedical, LLC took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 252 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 9 | 9 |
| NZP | Sealant, Microbial | 3 | 3 |
Review panels
Most recent Adhezion Biomedical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223669 | SecurePortIV Advanced Catheter Securement Adhesive | NZP | 2023-06-12 | 187 |
| K170505 | SecurePortIV Catheter Securement Adhesive | NZP | 2017-09-29 | 220 |
| K161011 | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive | MPN | 2016-11-08 | 211 |
| K150866 | SURGISEAL Topical Skin Adhesvie | MPN | 2015-07-17 | 107 |
| K133963 | SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE | MPN | 2014-09-09 | 259 |
| K141215 | SURGISEAL TWIST TOPICAL SKIN ADHESIVE | MPN | 2014-08-21 | 101 |
| K140517 | SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE | MPN | 2014-04-28 | 59 |
| K130329 | SURGISEAL TOPICAL SKIN ADHESIVE | MPN | 2013-12-03 | 295 |
| K130474 | SURGISEAL TOPICAL SKIN ADHESIVE | MPN | 2013-05-31 | 95 |
| K123936 | SURGISEAL TOPICAL SKIN ADHESIVE | MPN | 2013-04-24 | 125 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Adhezion Biomedical, LLC.
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 Adhezion Biomedical, LLC?
FDA lists 12 510(k) clearances under the applicant name “Adhezion Biomedical, LLC” (first 2008, latest 2023), 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 Adhezion Biomedical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adhezion Biomedical, LLC is 156 days.
Which FDA product codes appear under Adhezion Biomedical, LLC?
The most frequent FDA product codes under this applicant name are MPN (Tissue Adhesive For The Topical Approximation Of Skin, 9); NZP (Sealant, Microbial, 3).
Next steps
- See all 12 Adhezion Biomedical, LLC clearances with predicates and recalls
- Run predicate analysis for product code MPN, Adhezion Biomedical, LLC'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.