'cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture

• • Terminated Z-1017-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007 ·on shared 510(k) K001434

  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

K001434 ↗

FDA Product Code

GAT

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

SN

• Nextstitch Cardiovascular Valve Suture

  Class II

  FDA 510(k) K001440 Active Cleared 13 Nov 2000

• Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250

  Class II

  FDA 510(k) K982712 Active Cleared 18 Dec 1998

• Saphlift

  Class I

  FDA 510(k) K990062 Active Cleared 30 Mar 1999

• Cutalon Nylon Polyamide Surgical Suture

  Class II

  FDA 510(k) K981322 Active Cleared 7 Jul 1998

• Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture

  Class II

  FDA 510(k) K992088 Active Cleared 3 Sep 1999

• Endoscopic Camera

  Class II

  FDA 510(k) K991416 Active Cleared 20 Jul 1999

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