Storz Microsurgical Bipolar Coagulator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883060 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• The Dextra Precision Power Unit

  Class I

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  Class II

  FDA 510(k) K934445 Active Cleared 11 Apr 1994

• Storz Premiere II Microsurgical System (Cx Series)

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  FDA 510(k) K961310 Active Cleared 27 Jun 1996

• Storz E9050 & E9055 Diamond Knives

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  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

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