510(k) K103437 ยท FDX Endoscopic Cytology Brush
US ENDOSCOPY CYTOLOGY BRUSH
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, Dec 23, 2010 |
| Received | Nov 23, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2012 | US Endoscopy Group Inc Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060
The Infinity sampling device is a disposable cytology brush used to retrieve cytolog Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.