510(k) K131953 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
IMAGE1 SPIES
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Jun 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2016 | Karl Storz Endoscopy Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope Terminated |
FET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.