510(k) K082066 ยท HFE Brush, Endometrial
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
| Applicant | Cook Urological, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Nov 7, 2008 |
| Received | Jul 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082066
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2009 | Cook OB/Gyn, Inc. Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL.
Used to obtain endometrial samples for Terminated |
HFE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.