FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Electrosurgical accessory
K Number: K210394
·
Decision May 19, 2021
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
57
Applicant Total
40
Review Days
98
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Basic Information
- Device Name
- Electrosurgical accessory
- K Number
- K210394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dornier Medtech America, Inc.
- Date Received
- February 10, 2021
- Decision Date
- May 19, 2021
- Product Code
- FAS
- 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 |
|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | FDA class 2 | Gastroenterology, Urology |
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