510(k) K002788 ยท GWG Endoscope, Neurological
KSEA NEURO-FIBERSCOPE
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Oct 23, 2000 |
| Received | Sep 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2019 | Karl Storz Endoscopy Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope Open, Classified |
GWG | None listed |
| Aug 27, 2019 | Karl Storz Endoscopy Karl Storz, Model # 11161C2, Flexible Neuroscope Open, Classified |
GWG | None listed |
| Aug 27, 2019 | Karl Storz Endoscopy Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1 Open, Classified |
GWG | None listed |
| Feb 20, 2019 | Karl Storz Endoscopy FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 Terminated |
GWG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.