FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILVER OSTEOTOME
K Number: K772374
·
Decision Mar 9, 1978
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
10
Applicant Total
140
Review Days
72
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Basic Information
- Device Name
- SILVER OSTEOTOME
- K Number
- K772374
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- December 27, 1977
- Decision Date
- March 9, 1978
- Product Code
- KDG
- 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 |
|---|---|---|---|
| KDG | Chisel (Osteotome) | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Edward Weck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915378 | WECK TROCAR | Jun 29, 1992 | Substantially Equivalent |
| K914690 | LM15(TM), CATALOG NUMBER - 523821 | Mar 23, 1992 | Substantially Equivalent |
| K911915 | HEMOCLIP II | Jan 9, 1992 | Substantially Equivalent |
| K914470 | PNEUMO-SEAL(TM) | Nov 29, 1991 | Substantially Equivalent |
| K911272 | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | Jul 2, 1991 | Substantially Equivalent |
| K902108 | HEM-O-LOK(TM) | Aug 6, 1990 | Substantially Equivalent |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | Aug 2, 1990 | Substantially Equivalent |
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | Feb 15, 1990 | Substantially Equivalent |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | Aug 27, 1987 | Substantially Equivalent |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | Jul 2, 1985 | Substantially Equivalent |