510(k) K981458 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
| Applicant | Karl Storz Endoscopy, Culver City CA, US |
| Decision | Substantially Equivalent, May 20, 1998 |
| Received | Apr 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | Karl Storz Endoscopy America Inc Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1.
" Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, unc Terminated |
ECQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.