Ksea Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope, 11001RK, 11002BC & 110

• • Terminated Z-0527-2014 FDA Class II ·initiated 13 Nov 2013 ·on shared 510(k) K981458

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K981458 ↗

FDA Product Code

EOB

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Ksea Gaab Neuroendoscope and Chavantes-Zaamorano Neuroendoscope Sets

  Class II

  FDA 510(k) K982837 Active Cleared 6 Nov 1998

• Ksea Quadro Switch

  Class II

  FDA 510(k) K021776 Active Cleared 15 Aug 2002

• Autocon II 200 Electrosurgical Generator

  Class II

  FDA 510(k) K023924 Active Cleared 21 Feb 2003

• Ksea Plastic Trocars

  Class II

  FDA 510(k) K974366 Active Cleared 8 Jan 1998

• Ksea Culdocentesis Set

  Class II

  FDA 510(k) K962881 Active Cleared 22 Oct 1996

• Hand Extractor Hector

  Class II

  FDA 510(k) K953109 Active Cleared 25 Aug 1995

See all devices from Karl Storz Endoscopy →