Storz S2060-C & DP9040 Bipolar Ccord Adaptors

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K954253 ↗

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

  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. →

• What is the primary function of the Storz S2060-C and DP9040 adaptors?

  These devices serve as electrosurgical accessories designed to facilitate the connection and operation of bipolar instruments within an electrosurgical system. They are specifically used to support cutting and coagulation procedures.

• What is the regulatory classification of these bipolar adaptors?

  The Storz S2060-C and DP9040 Bipolar Ccord Adaptors are classified as Class II medical devices. They have received FDA 510(k) clearance under the number K954253, which indicates they have been found substantially equivalent to legally marketed predicate devices.

• Under which product category are these Storz adaptors filed?

  These devices are categorized under the GEI product code, which pertains to electrosurgical, cutting, and coagulation accessories. This classification is used by the FDA to group devices with similar intended uses and technological characteristics for regulatory review.