FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTTER ELECTROSURGICAL CABLES
K Number: K073450
·
Decision Mar 17, 2008
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
98
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Basic Information
- Device Name
- SUTTER ELECTROSURGICAL CABLES
- K Number
- K073450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sutter Medizintechnik GmbH
- Date Received
- December 10, 2007
- Decision Date
- March 17, 2008
- 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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| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Feb 10, 2020 | Substantially Equivalent |
| K192128 | Sutter Arrowtip Monopolar Electrodes | Oct 4, 2019 | Substantially Equivalent |
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| K171869 | Sutter CURIS RF Generator | Feb 23, 2018 | Substantially Equivalent |
| K150959 | Sutter Bipolar Forceps-Calvian | Sep 10, 2015 | Substantially Equivalent |
| K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | Aug 23, 2013 | Substantially Equivalent |