Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration

• • Terminated Z-0527-2015 FDA Class II ·initiated 11 Nov 2014 ·on shared 510(k) K934320

  The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

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

510(k) Number

K934320 ↗

FDA Product Code

HQR

Device Class

Class II

Regulation

21 CFR Part 886.4100

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Mentor B-Vat(Tm) II Video Tester

  Class I

  FDA 510(k) K875112 Active Cleared 8 Mar 1988

• Binocular Indirect Ophthalmoscope

  Class II

  FDA 510(k) K843304 Active Cleared 21 Nov 1984

• Surg-E-Trol System I and System II

  Class II

  FDA 510(k) K890622 Active Cleared 4 May 1989

• Maid Mentor Aspiration/Irrigation Devro

  Class II

  FDA 510(k) K853382 Active Cleared 4 Oct 1985

• Mentor Horizon Low Vision Magnifier

  Class I

  FDA 510(k) K915340 Active Cleared 30 Mar 1992

• Mentor(R) Sur-E-Trol(R)

  Class II

  FDA 510(k) K910637 Active Cleared 13 May 1991

See all devices from Mentor O & O, Inc. →