Karl Storz Endoscopy-america, Inc.CALClass I

Laryngoscope, Non-rigid

Karl Storz Endoscopy-america, Inc.'s record for this product code

MDR events5All time

Recalls1All time

510(k) clearances0All time

Recent MDR events

5 adverse event reports on file

Recalls

1 recall events for this product code

TerminatedDec 17, 2013
KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Karl Storz Endoscopy-america, Inc. under this product code.