VANGUARD REPROCESSED ARTHROSCOPIC WANDS
FDA 510(k) clearance K012695 · decided 2001-10-30
Clearance details
- K-number
- K012695
- Device name
- VANGUARD REPROCESSED ARTHROSCOPIC WANDS
- Applicant
- Vanguard Medical Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-14
- Decision date
- 2001-10-30
- Days to decision
- 77 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
- Lakeland, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue recall (Z-1204-2012) | Stryker Sustainability Solutions, Inc. | 2012-03-13 |
| Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device -- Orthopedic Arthroscop recall (Z-1667-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device -- Orthopedic Arthroscope. recall (Z-1668-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. recall (Z-1670-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. recall (Z-1681-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |