510(k) K954797 ยท EOQ Bronchoscope (Flexible Or Rigid)
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Jan 17, 1996 |
| Received | Oct 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954797
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2024 | Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only Open, Classified |
EOQ | None listed |
| 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.