510(k) K052104 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION
| Applicant | Conmed Corporation, Centennial CO, US |
| Decision | Substantially Equivalent, Oct 21, 2005 |
| Received | Aug 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052104
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2009 | ConMed Electrosurgery * (Box label) SUCTION COAGULATOR 10FR QTY 25 *****
* (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE
*****
LOT 09GHL001 July 2014
MADE IN CHINA ** CONMED CORPO Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.