510(k) K012695 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
| Applicant | Vanguard Medical Concepts, Inc., Lakeland FL, US |
| Decision | Substantially Equivalent, Oct 30, 2001 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2012 | Stryker Sustainability Solutions, Inc. The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic Terminated |
GEI | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.