CABOT MEDICAL BIPOLAR CUTTING FORCEPS
FDA 510(k) clearance K932293 · decided 1994-07-27
Clearance details
- K-number
- K932293
- Device name
- CABOT MEDICAL BIPOLAR CUTTING FORCEPS
- Applicant
- Cabot Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-11
- Decision date
- 1994-07-27
- Days to decision
- 442 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32 recall (Z-0613-2007) | Gyrus ACMI Corporation | 2007-03-13 |
| Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901 recall (Z-0614-2007) | Gyrus ACMI Corporation | 2007-03-13 |
| Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 0066 recall (Z-0615-2007) | Gyrus ACMI Corporation | 2007-03-13 |