Polyganics B.V.,: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Polyganics B.V.,” (first 2003, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 69 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 | 2 | 88 |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| JXI | Cuff, Nerve | 3 | 3 |
| LYA | Splint, Intranasal Septal | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| KCN | Ear Wick | 1 | 1 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 1 | 1 |
Review panels
Most recent Polyganics B.V., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141816 | HEMOPORE | LYA | 2014-10-23 | 108 |
| K141423 | NASOPORE-FD | LYA | 2014-08-07 | 69 |
| K112267 | NEUROLAC(R) NERVE GUIDE | JXI | 2011-10-20 | 73 |
| K070715 | NASOPORE EAR | NHB | 2007-05-07 | 54 |
| K062540 | NASOPORE EAR, MODELS ND04, ND05 | KCN | 2006-10-18 | 49 |
| K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ | LYA | 2005-11-21 | 110 |
| K050573 | NEUROLAC NERVE GUIDE | JXI | 2005-05-04 | 58 |
| K042811 | VIVOSORB SHEET, MODEL FS01 | FTL | 2004-11-08 | 27 |
| K032115 | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | JXI | 2003-10-10 | 93 |
Recalls
openFDA lists no recalls under a recalling firm named Polyganics B.V.,.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Polyganics Innovations BV (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polyganics B.V.,?
FDA lists 9 510(k) clearances under the applicant name “Polyganics B.V.,” (first 2003, latest 2014), across 5 product codes in 3 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 Polyganics B.V.,?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polyganics B.V., is 69 days.
Which FDA product codes appear under Polyganics B.V.,?
The most frequent FDA product codes under this applicant name are JXI (Cuff, Nerve, 3); LYA (Splint, Intranasal Septal, 3); FTL (Mesh, Surgical, Polymeric, 1).
Next steps
- See all 9 Polyganics B.V., clearances with predicates and recalls
- Run predicate analysis for product code JXI, Polyganics B.V.,'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.