Seikagaku Corp.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Seikagaku Corp.” (first 2001, latest 2001), plus 2 PMA decisions, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 | 0 | — |
| 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 |
|---|---|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular | 2 | 0 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Review panels
- Orthopedic (2)
- Ear, Nose and Throat (1)
Most recent Seikagaku Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011544 | HADGEL, 4 GRAM/SYRINGE | LYA | 2001-08-15 | 89 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080020 | PMA | GEL-ONE | 2011-03-22 |
| P980044 | PMA | SUPARTZ FX | 2001-01-24 |
Recalls
openFDA lists no recalls under a recalling firm named Seikagaku Corp..
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.
Device clinical trials
An industry sponsor named Seikagaku Corp. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01934218: Gel-One Treatment in Knee Osteoarthritis (Completed, started 2013-08)
- NCT00450112: Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee (Completed, started 2007-03)
- NCT00449696: Gel-200 Versus Placebo in Osteoarthritis of the Knee (Completed, started 2006-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under Seikagaku Corp.?
FDA lists 1 510(k) clearance under the applicant name “Seikagaku Corp.” (first 2001, latest 2001), plus 2 PMA decisions, 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 Seikagaku Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seikagaku Corp. is 89 days.
Which FDA product codes appear under Seikagaku Corp.?
The most frequent FDA product codes under this applicant name are MOZ (Acid, Hyaluronic, Intraarticular, 2); LYA (Splint, Intranasal Septal, 1).
Next steps
- See all 1 Seikagaku Corp. clearances with predicates and recalls
- Run predicate analysis for product code MOZ, Seikagaku Corp.'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.