FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
K Number: K233113
·
Decision Oct 25, 2023
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
11
Review Days
28
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Basic Information
- Device Name
- ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
- K Number
- K233113
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starmed Co., Ltd.
- Date Received
- September 27, 2023
- Decision Date
- October 25, 2023
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Starmed Co., Ltd.
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|---|---|---|---|
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| K234140 | VIVA combo RF System (VIVA combo RF System) | Jan 30, 2024 | Substantially Equivalent |
| K222997 | VVR Generator system | Oct 25, 2023 | Substantially Equivalent |
| K203795 | Star RF Electrode, VIVA RF Electrode | Apr 1, 2021 | Substantially Equivalent |
| K181758 | ELRA Electrode | Apr 11, 2019 | Substantially Equivalent |
| K183538 | VIVA combo RF System | Jan 17, 2019 | Substantially Equivalent |
| K181249 | EUSRA RF Electrode | Sep 4, 2018 | Substantially Equivalent |
| K172012 | star RF Electrode, VIVA RF Electrode | Mar 14, 2018 | Substantially Equivalent |
| K163450 | VIVA combo RF System | Mar 8, 2017 | Substantially Equivalent |