FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 80-1983, ELECTROSURGICAL GENERATOR
K Number: K931437
·
Decision May 27, 1994
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
14
Review Days
431
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Basic Information
- Device Name
- MODEL 80-1983, ELECTROSURGICAL GENERATOR
- K Number
- K931437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cameron-Miller, Inc.
- Date Received
- March 22, 1993
- Decision Date
- May 27, 1994
- 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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Other Clearances by Cameron-Miller, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944775 | ELECTROSURGICAL UNIT MODEL 26-0335 | Oct 11, 1994 | Substantially Equivalent |
| K931541 | MODEL 26-0375, ELECTROSURGICAL GENERATOR | Jun 1, 1994 | Substantially Equivalent |
| K935490 | ELECTROSURGICAL DEVICE, MODEL 26-2500 | Apr 1, 1994 | Substantially Equivalent |
| K853972 | CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR | Jan 24, 1986 | Substantially Equivalent |
| K854109 | ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 | Jan 24, 1986 | Substantially Equivalent |
| K833449 | HAND CONTROLLED PENCIL OR SWITCH HAND | Nov 29, 1983 | Substantially Equivalent |
| K822092 | CAMERON-MILLER #40-1516 | Sep 21, 1982 | Substantially Equivalent |
| K812702 | TECHNICATOR | Nov 5, 1981 | Substantially Equivalent |
| K791415 | MODEL 80-1765 ELECTROSURGICAL UNIT | Oct 11, 1979 | Substantially Equivalent |
| K781353 | PAPILLOTOME CUTTING SNARE | Oct 10, 1978 | Substantially Equivalent |