FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERNUM SAW BLADE
K Number: K802838
·
Decision Dec 11, 1980
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
19
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STERNUM SAW BLADE
- K Number
- K802838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Amsco Co.
- Date Received
- November 12, 1980
- Decision Date
- December 11, 1980
- Product Code
- GFA
- 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 |
|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFA), ordered by most recent decision date.
GRAFT HARVESTING SAWBLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER SAGITTAL SAW ATTACHMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WRIGHT MEDICAL TECHNOLOGY SAWBLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL SAW BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RE-SHARPENABLE SAW BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Amsco Co.
| K Number | Device Name | ||
|---|---|---|---|
| K912471 | EAGLE 3000 SDS | Jun 26, 1992 | Substantially Equivalent |
| K854922 | AMSCO POLARIS SL | Jan 24, 1986 | Substantially Equivalent |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Oct 19, 1983 | Substantially Equivalent |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent |
| K831086 | CEILING MOUNTED SUPPORT | Aug 12, 1983 | Substantially Equivalent |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent |
| K831309 | DELIVERY 4 TABLE | Jun 15, 1983 | Substantially Equivalent |
| K823360 | SURGICAL LIGHT | Dec 3, 1982 | Substantially Equivalent |