FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CORE-SPORT
K Number: K220081
·
Decision Sep 28, 2022
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
6
Review Days
261
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Basic Information
- Device Name
- CORE-SPORT
- K Number
- K220081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incore Co., Ltd.
- Date Received
- January 10, 2022
- Decision Date
- September 28, 2022
- Product Code
- OTJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OTJ | Laparoscopic Single Port Access Device | FDA class 2 | Gastroenterology, Urology |
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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 |
| K220846 | CORE-SNARE | Nov 21, 2022 | Substantially Equivalent |
| K213338 | CORE-CLIP | Jun 23, 2022 | Substantially Equivalent |
| K211148 | CORE-Trocar | Jun 21, 2022 | Substantially Equivalent |