Rosen's Stapes Needle Explorer

• • Terminated Z-0407-2013 FDA Class II ·initiated 17 Aug 2012

  There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

510(k) Number

K822277 ↗

FDA Product Code

KAK

Device Class

Class I

Regulation

21 CFR Part 874.4420

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Nagashima Light Source Unit Sl-5

  Class II

  FDA 510(k) K821709 Active Cleared 25 Jun 1982

• Lancets for Ear Surgery

  Class I

  FDA 510(k) K822279 Active Cleared 25 Aug 1982

• Adenotomes

  Class I

  FDA 510(k) K822262 Active Cleared 25 Aug 1982

• Tonsil Dissectors

  Class I

  FDA 510(k) K822187 Active Cleared 24 Aug 1982

• Mircosurgical Instruments

  Class I

  FDA 510(k) K822195 Active Cleared 25 Aug 1982

• ENT Forceps

  Class I

  FDA 510(k) K822278 Active Cleared 27 Aug 1982

See all devices from Kelleher Corp. →