Safety Holster, Single-Use

• • Terminated Z-0726-2013 FDA Class II ·initiated 27 Dec 2012

  ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.

510(k) Number

K790770 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Fiber Optic Adapter #60-0892

  Class I

  FDA 510(k) K802774 Active Cleared 16 Dec 1980

• Fiber Optic Light Guide CAT#60-0768

  Class I

  FDA 510(k) K802767 Active Cleared 16 Dec 1980

• Fiber Optic Headlight #60-0766766

  Class II

  FDA 510(k) K802770 Active Cleared 11 Dec 1980

• Fiber Optic ADAPTERS#60-0893

  Class II

  FDA 510(k) K810300 Active Cleared 27 Feb 1981

• A.T.S. 1500 Tourniquet

  Class I

  FDA 510(k) K870784 Active Cleared 18 Mar 1987

• Single Use Ball Electrode

  Class II

  FDA 510(k) K780976 Active Cleared 22 Jun 1978

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