FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CORE-SNARE
K Number: K220846
·
Decision Nov 21, 2022
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
62
Applicant Total
6
Review Days
243
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CORE-SNARE
- K Number
- K220846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incore Co., Ltd.
- Date Received
- March 23, 2022
- Decision Date
- November 21, 2022
- Product Code
- FDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDI | Snare, Flexible | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FDI), ordered by most recent decision date.
Advanced Tissue Resection Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polypectomy Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Polyp Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Polypectomy Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Incore Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Apr 19, 2024 | Substantially Equivalent |
| K221054 | CORE-INJECTOR | Dec 21, 2022 | Substantially Equivalent |
| K220081 | CORE-SPORT | Sep 28, 2022 | Substantially Equivalent |
| K213338 | CORE-CLIP | Jun 23, 2022 | Substantially Equivalent |
| K211148 | CORE-Trocar | Jun 21, 2022 | Substantially Equivalent |