FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO BLADE II
K Number: K812526
·
Decision Sep 16, 1981
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
10
Review Days
14
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Basic Information
- Device Name
- MICRO BLADE II
- K Number
- K812526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Vxtra Corp.
- Date Received
- September 2, 1981
- Decision Date
- September 16, 1981
- Product Code
- GES
- 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 |
|---|---|---|---|
| GES | Blade, Scalpel | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Vxtra Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832938 | OCUTOME PARATUBING SET | Oct 19, 1983 | Substantially Equivalent |
| K832980 | VXTRA OCUTOME KIT | Oct 19, 1983 | Substantially Equivalent |
| K831266 | MICROSURGICAL KNIFE | Jun 10, 1983 | Substantially Equivalent |
| K830385 | IRRIGATION/ASPIRATION KIT | Apr 5, 1983 | Substantially Equivalent |
| K830379 | PHAKO KIT | Apr 5, 1983 | Substantially Equivalent |
| K812620 | ADJUSTABLE MICROSURGICAL KNIFE | Oct 19, 1981 | Substantially Equivalent |
| K812160 | MICROSURGICAL BLADE | Aug 31, 1981 | Substantially Equivalent |
| K800557 | DISPOSABLE PRE-GELLED ELECTROSURGICAL | Apr 21, 1980 | Substantially Equivalent |
| K792436 | VXTRA BACK PACK EKG ELECTRODE CAT. NO. | Feb 22, 1980 | Substantially Equivalent |