FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIPOLAR CORD
K Number: K944578
·
Decision Dec 8, 1994
Classifications
1
FEI Numbers
839
Registration Numbers
839
Same Product Code
2251
Applicant Total
17
Review Days
80
Basic Information
- Device Name
- BIPOLAR CORD
- K Number
- K944578
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BOSTON SURGICAL PRODUCTS, INC.
- Date Received
- September 19, 1994
- Decision Date
- December 8, 1994
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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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 |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | Jul 12, 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 |