FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
K Number: K921386
·
Decision Oct 8, 1993
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
1
Review Days
564
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Basic Information
- Device Name
- SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
- K Number
- K921386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Silver Creek Surgical
- Date Received
- March 23, 1992
- Decision Date
- October 8, 1993
- Product Code
- HGI
- 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 |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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