510(k) K072521 ยท FFS Image, Illumination, Fiberoptic, For Endoscope
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Nov 20, 2007 |
| Received | Sep 7, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | Cook Inc. Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages Terminated |
FFS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.