FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYMBIOSIS BIPOLAR FORCEPS
K Number: K952432
·
Decision Jul 5, 1995
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
34
Review Days
42
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Basic Information
- Device Name
- SYMBIOSIS BIPOLAR FORCEPS
- K Number
- K952432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Symbiosis Corp.
- Date Received
- May 24, 1995
- Decision Date
- July 5, 1995
- 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 Symbiosis Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955119 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Jan 18, 1996 | Substantially Equivalent |
| K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Jan 17, 1996 | Substantially Equivalent |
| K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES | Oct 6, 1995 | Substantially Equivalent |
| K951387 | SYMBIOSIS BIPOLAR SCISSORS | Apr 10, 1995 | Substantially Equivalent |
| K950286 | SYMBIOSIS BIPOLAR SCISSORS | Feb 3, 1995 | Substantially Equivalent |
| K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS | Jan 20, 1995 | Substantially Equivalent |
| K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | Jul 28, 1994 | Substantially Equivalent |
| K941426 | SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE | Jun 22, 1994 | Substantially Equivalent |
| K932266 | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN | Mar 15, 1994 | Substantially Equivalent |
| K931957 | SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS | Feb 28, 1994 | Substantially Equivalent |