FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
K Number: K111751
·
Decision Dec 2, 2011
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
15
Applicant Total
204
Review Days
163
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Basic Information
- Device Name
- VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
- K Number
- K111751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON, Inc.
- Date Received
- June 22, 2011
- Decision Date
- December 2, 2011
- Product Code
- HIN
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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