Suture Nonabsorbable-Nylon, Silk, Polyester, Stainles

• • Terminated Z-0034-2009 FDA Unclassified (pre-2012) ·initiated 9 Sep 2008 ·via K930825, on the same 510(k)

  mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K930825 ↗

FDA Product Code

GAP

Device Class

Class II

Regulation

21 CFR Part 878.5030

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Monoderm

  Class II

  FDA 510(k) K040477 Active Cleared 18 May 2004

• Suture Absorbable- Gut

  Class II

  FDA 510(k) K932037 Active Cleared 7 Jan 1994

• S3 Medicated Gauze

  Unclassified

  FDA 510(k) K874219 Active Cleared 23 Nov 1987

• Quill Self-Retaining System (Srs) Synthetic Absorbable Surgical Suture Material

  Class II

  FDA 510(k) K071989 Active Cleared 6 Aug 2007

• Modified Monoderm Monofilament, Synthetic, Absorbable Suture

  Class II

  FDA 510(k) K052437 Active Cleared 7 Nov 2005

• S1 Nasal Packing

  Unclassified

  FDA 510(k) K861444 Active Cleared 6 May 1986

See all devices from Surgical Specialties Corp →