FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)
K Number: K100641
·
Decision Mar 30, 2010
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
25
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Basic Information
- Device Name
- INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)
- K Number
- K100641
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Relievant Medsystems
- Date Received
- March 5, 2010
- Decision Date
- March 30, 2010
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Relievant Medsystems
| K Number | Device Name | ||
|---|---|---|---|
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | May 3, 2019 | Substantially Equivalent |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Sep 14, 2018 | Substantially Equivalent |
| K171143 | Relievant Medsystems RF Generator | Aug 18, 2017 | Substantially Equivalent |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Aug 9, 2017 | Substantially Equivalent |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Jul 9, 2016 | Substantially Equivalent |