FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE MONOPOLAR HAND CONTROL PENCIL
K Number: K791137
·
Decision Jul 24, 1979
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
50
Review Days
36
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Basic Information
- Device Name
- SINGLE USE MONOPOLAR HAND CONTROL PENCIL
- K Number
- K791137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Davol, Inc.
- Date Received
- June 18, 1979
- Decision Date
- July 24, 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 |
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|---|---|---|---|
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| K031213 | AQUASENS FLUID MONITORING SYSTEM | Apr 30, 2003 | Substantially Equivalent |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | Feb 13, 2003 | Substantially Equivalent |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | Jan 22, 2001 | Substantially Equivalent |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | Dec 22, 2000 | Substantially Equivalent |
| K931899 | DAVOL ATS | Nov 15, 1994 | Substantially Equivalent |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | Jun 14, 1994 | Substantially Equivalent |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Mar 25, 1994 | Substantially Equivalent |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | Mar 7, 1994 | Substantially Equivalent |