FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROSURGICAL UNIT
K Number: K812203
·
Decision Oct 13, 1981
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
70
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Basic Information
- Device Name
- ELECTROSURGICAL UNIT
- K Number
- K812203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Reznik Instruments
- Date Received
- August 4, 1981
- Decision Date
- October 13, 1981
- 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 Reznik Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K812205 | FORCEP | Oct 26, 1981 | Substantially Equivalent |
| K812201 | PHOTOGRAPHIC EQUIPMENT | Oct 19, 1981 | Substantially Equivalent |
| K812206 | LAPAROSCOPE | Oct 13, 1981 | Substantially Equivalent |
| K812199 | TROCAR & TROCAR SLEEVES | Oct 13, 1981 | Substantially Equivalent |
| K812204 | UTERINE MANIPULATORS | Oct 13, 1981 | Substantially Equivalent |
| K812200 | INSUFFLATOR | Sep 29, 1981 | Substantially Equivalent |
| K812202 | FIBER OPTIC LIGHT SOURCE | Sep 29, 1981 | Substantially Equivalent |
| K812198 | ACCESSORIES(PROBES, SUCTION TUBES, ETC.) | Sep 11, 1981 | Substantially Equivalent |