Surgairtome Two

• • Terminated Z-0711-2008 FDA Unclassified (pre-2012) ·initiated 9 Aug 2007 ·on shared 510(k) K781979

  Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.

• • Terminated Z-0041-05 FDA Unclassified (pre-2012) ·initiated 26 Aug 2004 ·on shared 510(k) K781979

  The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

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

510(k) Number

K781979 ↗

FDA Product Code

HSZ

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Biological/Chemical Indicator Proof Flash

  Class II

  FDA 510(k) K850144 Active Cleared 17 Jun 1985

• Minor Surgical Light Model 180

  Class II

  FDA 510(k) K841360 Active Cleared 24 Apr 1984

• Hall Arterial Oscillator

  Class II

  FDA 510(k) K801063 Active Cleared 26 Sep 1980

• Vantage E

  Class II

  FDA 510(k) K841156 Active Cleared 13 Apr 1984

• Amsco Orthographic 2 Table

  Class I

  FDA 510(k) K823772 Active Cleared 14 Jan 1983

• Amsco SQ240 Surgical Light

  Class II

  FDA 510(k) K943288 Active Cleared 17 Oct 1994

See all devices from American Sterilizer Co. →