510(k) K912780 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
| Applicant | Electroscope, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Dec 30, 1991 |
| Received | Jun 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2011 | Encision, Inc. ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | None listed |
| May 31, 2011 | Encision, Inc. ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | None listed |
| May 31, 2011 | Encision, Inc. ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | None listed |
| May 31, 2011 | Encision, Inc. ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | None listed |
| May 31, 2011 | Encision, Inc. ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | None listed |
| May 31, 2011 | Encision, Inc. ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures Terminated |
GEI | None listed |
| Sep 22, 2004 | Encision, Inc. AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable. Terminated |
GEI | None listed |
| Jan 30, 2003 | Encision, Inc. AEM Fixed-Tip Needle Electrode - 5mm, Reusable
REF/CAT ES3521B Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.