Storz Premiere II Microsurgical System (Cx Series)

• • Terminated Z-1663-2010 FDA Unclassified (pre-2012) ·initiated 15 Jan 2010 ·on shared 510(k) K961310

  The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.

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

510(k) Number

K961310 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• The Dextra Precision Power Unit

  Class I

  FDA 510(k) K853778 Active Cleared 13 Nov 1985

• Ststorz DP5300 and DP9502 Sterile Drapes

  Class II

  FDA 510(k) K934445 Active Cleared 11 Apr 1994

• Storz E9050 & E9055 Diamond Knives

  Class I

  FDA 510(k) K861732 Active Cleared 28 May 1986

• Storz Reus 20/25 Gauge Vitre Cut W/Reus Hand/Driv

  Class II

  FDA 510(k) K924604 Active Cleared 27 Nov 1992

• Storz Premiere/Premiere Microvit Microsurg Systems

  Class II

  FDA 510(k) K921460 Active Cleared 2 Jul 1992

• Storz Universal Eye Shield

  Class I

  FDA 510(k) K841599 Active Cleared 22 May 1984

See all devices from Storz Instrument Co. →