FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K Number: K023924
·
Decision Feb 21, 2003
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
35
Review Days
88
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Basic Information
- Device Name
- AUTOCON II 200 ELECTROSURGICAL GENERATOR
- K Number
- K023924
- 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
- Karl Storz Endoscopy
- Date Received
- November 25, 2002
- Decision Date
- February 21, 2003
- 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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| K021776 | KSEA QUADRO SWITCH | Aug 15, 2002 | Substantially Equivalent |
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| K011841 | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR | Sep 10, 2001 | Substantially Equivalent |
| K010569 | KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP | Apr 9, 2001 | Substantially Equivalent |
| K004037 | X-RAY SYSTEM XR-MX | Feb 2, 2001 | Substantially Equivalent |