FDA Registration
Active
🇰🇷 South Korea
INCORE CO., LTD.
Reg #: 3017390965
·
FEI: 3017390965
·
Expires 2026
Products
8
Proprietary Names
15
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- INCORE CO., LTD.
- Registration Number
- 3017390965
- FEI Number
- 3017390965
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11, Hyeoksin-daero 78-gil, Dong-gu
- City
- Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K211148
Owner / Operator
- Firm Name
- INCORE Co., Ltd.
- Operator Number
- 10075609
- Address
- 11, Hyeoksin-daero 78-gil, Dong-gu
- City
- Daegu
- State
- KR-NOTA
- Postal Code
- 41072
- Country
- KR
- Correspondent
- Dong-Tak Kim
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-05-14 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-07-27 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-07-27 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2025-09-04 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2025-09-04 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2020-06-20 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2025-09-03 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-06-20 |
Proprietary Names
CORE-Trocar
Becagel
HYLACELL M
LACUDY M
CELRETA
LACUDY
Gynoseal
HYLACELL
S-Cudy
CORE-INJECTOR
CORE-SNARE
CORE-MEDIUM
Ex Free Medium
CORE-CLIP
CORE-SWAB
Establishment Types
Manufacture Medical Device