FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 80-1765 ELECTROSURGICAL UNIT
K Number: K791415
·
Decision Oct 11, 1979
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
14
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL 80-1765 ELECTROSURGICAL UNIT
- K Number
- K791415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cameron-Miller, Inc.
- Date Received
- July 31, 1979
- Decision Date
- October 11, 1979
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K931437 | MODEL 80-1983, ELECTROSURGICAL GENERATOR | May 27, 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 |
| K781353 | PAPILLOTOME CUTTING SNARE | Oct 10, 1978 | Substantially Equivalent |