510(k) K961505 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
| Applicant | Conmedcorp, Dayton OH, US |
| Decision | Substantially Equivalent, Jul 18, 1996 |
| Received | Apr 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2010 | ConMed Electrosurgery ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (pouch label)
ABC Bend-A-Beam Han Terminated |
GEI | None listed |
| Aug 25, 2010 | ConMed Electrosurgery ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label)
ABC Bend-A-Beam Ha Terminated |
GEI | None listed |
| Aug 25, 2010 | ConMed Electrosurgery ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label)
ABC Bend-A-Beam Ha Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.