Sterile Black Monofilament Nylon Non-Absor. Suture

• • Terminated Z-2138-2011 FDA Unclassified (pre-2012) ·initiated 30 Mar 2011 ·on shared 510(k) K903029

  Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.

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

510(k) Number

K903029 ↗

FDA Product Code

GAR

Device Class

Class II

Regulation

21 CFR Part 878.5020

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K872884 Active Cleared 10 Aug 1987

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  FDA 510(k) K913530 Active Cleared 21 Oct 1991

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• What is the primary purpose of this suture?

  This device is a non-absorbable, synthetic polyamide suture intended for use in wound closure and tissue repair during surgical procedures.

• Is this suture intended for reuse?

  No, this device is intended for single use only. It is supplied in a sterile state to ensure patient safety and must be discarded after the initial surgical application.

• What are the physical characteristics of this suture?

  The suture features a monofilament construction, which provides a smooth surface. This design is intended to facilitate the passage of the suture through tissue during surgical procedures.

• How is this device regulated?

  This suture is regulated under FDA 510(k) clearance K903029, which confirms its status as substantially equivalent to existing devices for its intended use in general and plastic surgery.