MIDAS TOUCH BIPOLAR FORCEPS
FDA 510(k) clearance K982705 · decided 1998-09-08
Clearance details
- K-number
- K982705
- Device name
- MIDAS TOUCH BIPOLAR FORCEPS
- Applicant
- Iti Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-03
- Decision date
- 1998-09-08
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Livermore, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reus recall (Z-1995-2012) | PSC Industries Inc | 2012-07-12 |