FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
K Number: K955119
·
Decision Jan 18, 1996
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
34
Review Days
70
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Basic Information
- Device Name
- SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
- K Number
- K955119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Symbiosis Corp.
- Date Received
- November 9, 1995
- Decision Date
- January 18, 1996
- Product Code
- HIH
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Symbiosis Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Jan 17, 1996 | Substantially Equivalent |
| K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES | Oct 6, 1995 | Substantially Equivalent |
| K952432 | SYMBIOSIS BIPOLAR FORCEPS | Jul 5, 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 |