Gunze Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gunze Limited” (first 2013, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 219 days. Since 2017 the median was 175 days, against 162 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 219 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 279 |
| 2021 | 0 | — |
| 2022 | 3 | 95 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gunze Limited took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 3 | 3 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 2 | 2 |
Review panels
Most recent Gunze Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221487 | NEOVEIL Staple Line Reinforcement | OXC | 2022-08-26 | 95 |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | KGN | 2022-07-14 | 255 |
| K213573 | PELNAC Wound Matrix | KGN | 2022-02-09 | 91 |
| K191992 | PELNAC Bilayer Wound Matrix | KGN | 2020-04-29 | 279 |
| K130997 | NEOVEIL | OXC | 2013-11-15 | 219 |
Recalls
openFDA lists no recalls under a recalling firm named Gunze Limited.
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 Gunze Limited?
FDA lists 5 510(k) clearances under the applicant name “Gunze Limited” (first 2013, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gunze Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gunze Limited is 219 days. Since 2017: 175 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gunze Limited?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 3); OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement, 2).
Next steps
- See all 5 Gunze Limited clearances with predicates and recalls
- Run predicate analysis for product code KGN, Gunze Limited'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.