FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
K Number: K953012
·
Decision Jul 12, 1995
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
17
Review Days
14
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
- DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
- K Number
- K953012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Surgical Products, Inc.
- Date Received
- June 28, 1995
- Decision Date
- July 12, 1995
- 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
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
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Boston Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972311 | MODEL 20 BIPOLAR COAGULATOR | Sep 18, 1997 | Substantially Equivalent |
| K972350 | MODEL 50 BIPOLAR COAGULATOR | Aug 21, 1997 | Substantially Equivalent |
| K944947 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS | Jul 28, 1995 | Substantially Equivalent |
| K950375 | DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR | Jun 14, 1995 | Substantially Equivalent |
| K951912 | DISOPOSABLE & RESUABLE MONPOLAR CORD | May 12, 1995 | Substantially Equivalent |
| K951269 | DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL | Apr 24, 1995 | Substantially Equivalent |
| K950877 | REUSABLE MONOPOLAR FORCEPS | Mar 9, 1995 | Substantially Equivalent |
| K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | Feb 8, 1995 | Substantially Equivalent |
| K945893 | DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE | Dec 13, 1994 | Substantially Equivalent |
| K944634 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Dec 8, 1994 | Substantially Equivalent |