510(k) K936304 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ELECTROSURGICAL PENCIL
| Applicant | E & M Engineering, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jun 13, 1994 |
| Received | Dec 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936304
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2018 | Olsen Medical Symmetry Olsen Monopolar Pencil:
(a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50
(b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50
(c) Rocker Switchpen, w/ Stan Terminated |
GEI | None listed |
| Jul 11, 2012 | PSC Industries Inc Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pou Terminated |
GEI | None listed |
| Jul 11, 2012 | PSC Industries Inc Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyv Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.