Incore Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Incore Co., Ltd.” (first 2022, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 260 days. Since 2017 the median was 260 days, against 116 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 |
|---|---|---|
| 2022 | 5 | 259 |
| 2023 | 0 | — |
| 2024 | 1 | 268 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Incore Co., Ltd. took a median 260 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| OTJ | Laparoscopic Single Port Access Device | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
Most recent Incore Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | QSY | 2024-04-19 | 268 |
| K221054 | CORE-INJECTOR | FBK | 2022-12-21 | 254 |
| K220846 | CORE-SNARE | FDI | 2022-11-21 | 243 |
| K220081 | CORE-SPORT | OTJ | 2022-09-28 | 261 |
| K213338 | CORE-CLIP | PKL | 2022-06-23 | 259 |
| K211148 | CORE-Trocar | GCJ | 2022-06-21 | 428 |
Recalls
openFDA lists no recalls under a recalling firm named Incore 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Incore Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Incore Co., Ltd.” (first 2022, latest 2024), across 6 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 Incore Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Incore Co., Ltd. is 260 days. Since 2017: 260 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Incore Co., Ltd.?
The most frequent FDA product codes under this applicant name are FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FDI (Snare, Flexible, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 6 Incore Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FBK, Incore 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.