Sejong Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sejong Medical Co., Ltd.” (first 2017, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 105 days. Since 2017 the median was 105 days, against 108 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 |
|---|---|---|
| 2017 | 4 | 69 |
| 2018 | 1 | 231 |
| 2019 | 0 | — |
| 2020 | 1 | 24 |
| 2021 | 1 | 568 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 250 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sejong Medical Co., Ltd. took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
Review panels
Most recent Sejong Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253165 | LAP-iX2N | GEI | 2026-06-09 | 256 |
| K252985 | Laport | GCJ | 2026-05-19 | 243 |
| K200639 | LAP-iX | GEI | 2021-09-29 | 568 |
| K200638 | LAP-iX Suction Irrigation | HET | 2020-04-03 | 24 |
| K173108 | Smoklean | FYD | 2018-05-18 | 231 |
| K173111 | LAP-iX Suction Irrigation | HET | 2017-11-28 | 60 |
| K173112 | LAP-iX | GEI | 2017-11-21 | 53 |
| K171726 | LapBag | GCJ | 2017-09-25 | 105 |
| K171741 | Laport | GCJ | 2017-08-29 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Sejong Medical Co., Ltd..
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.
- Sejong Healthcare Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sejong Medical Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Sejong Medical Co., Ltd.” (first 2017, latest 2026), across 4 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 Sejong Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sejong Medical Co., Ltd. is 105 days. Since 2017: 105 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sejong Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); HET (Laparoscope, Gynecologic (And Accessories), 2).
Next steps
- See all 9 Sejong Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Sejong Medical Co., Ltd.'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.