ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
FDA 510(k) clearance K012640 · decided 2002-02-28
Clearance details
- K-number
- K012640
- Device name
- ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
- Applicant
- Medical Instruments Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2002-02-28
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- St. George, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope. recall (Z-1680-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |