510(k) K111262 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
| Applicant | Olsen Medical, Louisville KY, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | May 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111262
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2018 | Olsen Medical Symmetry Olsen bipolar cord:
(a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50
(b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10
Terminated |
GEI | None listed |
| May 11, 2018 | Olsen Medical Symmetry Olsen monopolar cord:
(a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50
(b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10
(c) Mo Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.