Sterile/Single Use Eye Sphere Implants

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K921106 ↗

FDA Product Code

HPZ

Device Class

Class II

Regulation

21 CFR Part 886.3320

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 Premiere Ii Microsurgical System (Cx Series)

  Class II

  FDA 510(k) K961310 Active Cleared 27 Jun 1996

• 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

See all devices from Storz Instrument Co. →