510(k) K091074 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Aug 17, 2009 |
| Received | Apr 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Encision, Inc. AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection an Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopo Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of mono Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of mon Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopola Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopolar high-fr Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monop Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of monopol Terminated |
GEI | None listed |
| May 6, 2010 | Encision, Inc. AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan.
Electrosurgical accessories intended, by use of mono Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.