FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ELRA Electrode
K Number: K181758
·
Decision Apr 11, 2019
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
11
Review Days
283
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Basic Information
- Device Name
- ELRA Electrode
- K Number
- K181758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starmed Co., Ltd.
- Date Received
- July 2, 2018
- Decision Date
- April 11, 2019
- 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.
| K Number | Device Name | ||
|---|---|---|---|
| K252833 | VIVA combo RF System | May 26, 2026 | Substantially Equivalent |
| K251566 | TS-RF Generator (STS10) | Nov 17, 2025 | Substantially Equivalent |
| K234140 | VIVA combo RF System (VIVA combo RF System) | Jan 30, 2024 | Substantially Equivalent |
| K222997 | VVR Generator system | Oct 25, 2023 | Substantially Equivalent |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Oct 25, 2023 | Substantially Equivalent |
| K203795 | Star RF Electrode, VIVA RF Electrode | Apr 1, 2021 | 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 |