510(k) K100711 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SUCTION IRRIGATION ELECTRODES AND ADAPTERS
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jun 9, 2010 |
| Received | Mar 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100711
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, L-Diamond,
REF ES3881.
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and Terminated |
GEI | None listed |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, Spatula,
REF ES3882,
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and i Terminated |
GEI | None listed |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, L-Hook,
REF ES3883,
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and ir Terminated |
GEI | None listed |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, J-Hook,
REF ES3884.
Encision Inc.,
Boulder, CO 80301.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irr Terminated |
GEI | None listed |
| Aug 30, 2011 | Encision, Inc. Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.