FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISP. MICROSURGICAL KNIVES
K Number: K821737
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
14
Review Days
18
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Basic Information
- Device Name
- DISP. MICROSURGICAL KNIVES
- K Number
- K821737
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Coburn Optical Ind., Inc.
- Date Received
- June 14, 1982
- Decision Date
- July 2, 1982
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GES), ordered by most recent decision date.
PERSONNA PLUS SAFETY SCALPEL SYSTEM
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PRECISION GLIDE - ENHANCED SURGICAL BLADE
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STERILE CARBON STEEL SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Coburn Optical Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892351 | MAGNILINK SYSTEM 602 | May 26, 1989 | Substantially Equivalent |
| K892350 | MAGNILINK SYSTEM 402/5 | May 26, 1989 | Substantially Equivalent |
| K892349 | MAGNILINK SYSTEM 209 | May 26, 1989 | Substantially Equivalent |
| K892347 | MAGNILINK SYSTEM 101 | May 26, 1989 | Substantially Equivalent |
| K892348 | MAGNILINK SYSTEM 201 | May 26, 1989 | Substantially Equivalent |
| K862188 | IRRIGATION & ASPIRATION/VITRECTOMY DEVICE | Aug 21, 1986 | Substantially Equivalent |
| K853457 | COBURN I/A SYSTEM | Oct 15, 1985 | Substantially Equivalent |
| K812441 | DI-CROWN | Oct 6, 1981 | Substantially Equivalent |
| K803159 | AUTOMATED PERIMETERS | Feb 4, 1981 | Substantially Equivalent |
| K801659 | BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE | Sep 9, 1980 | Substantially Equivalent |