Sutures Polyprop., Polyetheline, Nylon & Silk

• • Terminated Z-1018-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007 ·on shared 510(k) K930739

  Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

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

510(k) Number

K930739 ↗

FDA Product Code

GAP

Device Class

Class II

Regulation

21 CFR Part 878.5030

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Pleur-Evac Chest Drainage Systems

  Class II

  FDA 510(k) K905768 Active Cleared 11 Feb 1991

• Deknatel Trocar Catheter

  Class II

  FDA 510(k) K873525 Active Cleared 2 Nov 1987

• Pleur-Evac(R) Adult/Pedi Dual Coll Chest Drain Sys

  Class II

  FDA 510(k) K924337 Active Cleared 28 Jul 1993

• Pleur-Evac Cardiotomy Reservoir # Cr-9400 & 9400F

  Class II

  FDA 510(k) K926338 Active Cleared 26 Jul 1994

• Pleur-Evac-A-7000--Adult/Pedi Chest Drainage Syst

  Class II

  FDA 510(k) K882223 Active Cleared 16 Aug 1988

• Deknatel Temporary Cardiac Pacing Wire

  Class II

  FDA 510(k) K873728 Active Cleared 3 Nov 1987

See all devices from Deknatel, Inc. →