FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMO STATIC/ESU SCALPEL SYSTEM
K Number: K842622
·
Decision Oct 23, 1984
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
110
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Basic Information
- Device Name
- HEMO STATIC/ESU SCALPEL SYSTEM
- K Number
- K842622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Oximetrix, Inc.
- Date Received
- July 5, 1984
- Decision Date
- October 23, 1984
- 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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Other Clearances by Oximetrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853018 | MODEL 3000 OPTICATH COMPUTER | Jan 13, 1986 | Substantially Equivalent |
| K833966 | PUMP INFUSION WEARABLE INFUSION PUMP | Jan 25, 1984 | Substantially Equivalent |
| K823007 | OPTICATH HEPARIN COATED, FLOW-DIRECT | Nov 1, 1982 | Substantially Equivalent |
| K821056 | FLOW DIRECTED THERMAL-DILUTION CATHETER | May 18, 1982 | Substantially Equivalent |
| K821057 | FLOW DIRECTED THERMAL-DILUTION INFUSION | May 18, 1982 | Substantially Equivalent |
| K820674 | OPTICATH | Mar 25, 1982 | Substantially Equivalent |
| K811391 | OXIMETRIX ACCU SAT CPB | Jul 20, 1981 | Substantially Equivalent |
| K791868 | OXIMETRIX SHAW HEMOSTATIC SURG. SYS. | Jan 4, 1980 | Substantially Equivalent |
| K781879 | HEATER, OXIMETER SYSTEM | Jan 8, 1979 | Substantially Equivalent |
| K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC | Aug 17, 1978 | Substantially Equivalent |