Dermahook #382-805

• 2 recalls, same reason

  • Terminated Z-1857-2008 FDA Unclassified (pre-2012) ·initiated 12 May 2008
  • Terminated Z-1856-2008 FDA Unclassified (pre-2012) ·initiated 12 May 2008

  The bands are breaking within the sealed packaging or in use prior to the expiration dates.

510(k) Number

K771187 ↗

FDA Product Code

GDG

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Farrior Oval Speculum

  Class I

  FDA 510(k) K772380 Active Cleared 17 Jan 1978

• Endoscopic Needlholder Cat. Number 114705

  Class II

  FDA 510(k) K911272 Active Cleared 2 Jul 1991

• Hooks #'s 7600, 7602, 7603, 7616

  Class I

  FDA 510(k) K791985 Active Cleared 4 Oct 1979

• Neivs Tracheotomy Retractor

  Class I

  FDA 510(k) K772378 Active Cleared 9 Mar 1978

• Hemoclip X-20 Automatic Hemoclip Ligating Applier

  Class II

  FDA 510(k) K844836 Active Cleared 23 Jan 1985

• Weck Tying Forcep, Straight Titanium

  Class I

  FDA 510(k) K761251 Active Cleared 16 Dec 1976

See all devices from Edward Weck, Inc. →