FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
K Number: K930773
·
Decision Jul 28, 1994
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
34
Review Days
527
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Basic Information
- Device Name
- SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
- K Number
- K930773
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Symbiosis Corp.
- Date Received
- February 16, 1993
- Decision Date
- July 28, 1994
- Product Code
- HFB
- 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 |
|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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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 |
| 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 |
| 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 |