FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROKNIFE
K Number: K821769
·
Decision Sep 14, 1982
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
20
Applicant Total
20
Review Days
96
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Basic Information
- Device Name
- MICROKNIFE
- K Number
- K821769
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Biological & Environmental Control Laboratories
- Date Received
- June 10, 1982
- Decision Date
- September 14, 1982
- Product Code
- EMF
- 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 |
|---|---|---|---|
| EMF | Knife, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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VAN-TEC ENDOPYELOTOMY KNIFE
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Other Clearances by Biological & Environmental Control Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER | Aug 18, 1997 | Substantially Equivalent |
| K962802 | SAFE MATE I.V. FLUID DELIVERY SETS | Aug 28, 1996 | Substantially Equivalent |
| K962801 | SAFE MATE I.V. EXTENSION SETS | Aug 28, 1996 | Substantially Equivalent |
| K961328 | BEC SHROUDED PLASTIC CANNULA | May 30, 1996 | Substantially Equivalent |
| K961327 | BEC NEEDLELESS INJECTION SITE | May 15, 1996 | Substantially Equivalent |
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | Nov 3, 1986 | Substantially Equivalent |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | Oct 16, 1986 | Substantially Equivalent |
| K863636 | UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS | Oct 6, 1986 | Substantially Equivalent |
| K863632 | UPDATED STERILE PROCEDURAL KIT | Sep 29, 1986 | Substantially Equivalent |
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | Sep 29, 1986 | Substantially Equivalent |