Biopsy Tray I & II

• • Terminated Z-2982-2011 FDA Unclassified (pre-2012) ·initiated 13 May 2011 ·on shared 510(k) K854095

  During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150,000 CFU. Our Alert Level is 17,000 CFU and the Action Level is 23,000 CFU.

• • Terminated Z-1572-05 FDA Unclassified (pre-2012) ·initiated 18 Jan 2005

  Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.

• • Terminated Z-1523-05 FDA Unclassified (pre-2012) ·initiated 23 Jun 2004

  Product contains the incorrect lot number.

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

510(k) Number

K854095 ↗

FDA Product Code

LRO

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESD Substantially Equivalent — Deferred

• Ivr-Sp Custom Angiography Tray

  Class II

  FDA 510(k) K870419 Active Cleared 11 May 1987

• Rct-1, Rct-2, Rct-3 Arthrogram Tray

  Class I

  FDA 510(k) K870417 Active Cleared 5 Mar 1987

• Ptc-6 and Ptc-8 Percutaneous Cholangiography

  Class I

  FDA 510(k) K870420 Active Cleared 14 Apr 1987

• Mya-1 and Myt-1 Myelogram Tray

  Not classified

  FDA 510(k) K870418 Active Cleared 17 Mar 1987

• LP Extension Sets

  Class II

  FDA 510(k) K870416 Active Cleared 6 Apr 1987