Deknatel(R) Microflex Ophthal Poly Suture, Modified

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911905 ↗

FDA Product Code

GAW

Device Class

Class II

Regulation

21 CFR Part 878.5010

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. →

• What types of ophthalmic procedures is the DEKNATEL® MICROFLEX OPHTHALMIC POLY SUTURE designed for, and why is it preferred in delicate surgeries?

  The DEKNATEL® MICROFLEX OPHTHALMIC POLY SUTURE is specifically designed for ophthalmic surgeries requiring durable closure of soft tissues, such as delicate procedures where long-term wound stability is critical. Its nonabsorbable, synthetic polypropylene composition provides strength and flexibility, making it ideal for intricate surgeries where sutures must remain intact for extended periods without degrading.

• How is the DEKNATEL® MICROFLEX OPHTHALMIC POLY SUTURE supplied, and what does this mean for clinical use?

  The suture is supplied in sterile, single-use packaging, ensuring aseptic conditions for surgical use. This means each package is intended for one procedure only, reducing the risk of contamination and ensuring compliance with infection control protocols in clinical settings.

• Are there multiple sizes and lengths available for this suture, and how do I determine which one to use?

  Yes, the DEKNATEL® MICROFLEX OPHTHALMIC POLY SUTURE comes in multiple sizes and lengths, as indicated by the associated FEI numbers (e.g., 3003495548, 3038718579, etc.). The variety allows for compatibility with different surgical requirements, such as varying tissue thickness or incision lengths. Consult the product documentation or manufacturer guidelines to match the suture size to the specific clinical need.

• Is this suture reusable, or is it intended for single-use only?

  The DEKNATEL® MICROFLEX OPHTHALMIC POLY SUTURE is explicitly supplied in sterile, single-use packaging, indicating it is intended for one-time use only. Reusing sutures could compromise sterility and patient safety, so adherence to single-use guidelines is essential.

• What regulatory pathway was followed for FDA clearance of this suture, and what does this mean for its use in clinical practice?

  The DEKNATEL® MICROFLEX OPHTHALMIC POLY SUTURE received FDA 510(k) clearance (K911905) under the General and Plastic Surgery advisory committee, classified as a Class II medical device. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for ophthalmic sutures in clinical practice.