FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT)
K Number: K844565
·
Decision Feb 21, 1985
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
90
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Basic Information
- Device Name
- BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT)
- K Number
- K844565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Clinical Technology Corp.
- Date Received
- November 23, 1984
- Decision Date
- February 21, 1985
- 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 Clinical Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925080 | TEK-LUBE | Jan 31, 1994 | Substantially Equivalent |
| K872867 | BIOSIGN | Jul 6, 1988 | Substantially Equivalent |
| K880166 | BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 | Feb 18, 1988 | Substantially Equivalent |
| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | Sep 1, 1987 | Substantially Equivalent |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Nov 10, 1986 | Substantially Equivalent |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | May 2, 1986 | Substantially Equivalent |
| K853507 | STERI-GRIP | Sep 5, 1985 | Substantially Equivalent |
| K852986 | GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN | Aug 19, 1985 | Substantially Equivalent |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Apr 13, 1984 | Substantially Equivalent |
| K823077 | URINARY BLADDER TEMP. SENSOR #81-003 | Mar 9, 1983 | Substantially Equivalent |