Mitek Absorbable Anchor

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K941599 ↗

FDA Product Code

MNV

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SN

• Mitek Drill Guide

  Class I

  FDA 510(k) K892904 Active Cleared 28 Sep 1989

• Mitek Super Quickanchor, Modification

  Class II

  FDA 510(k) K930893 Active Cleared 8 Dec 1993

• Braided Polyester Suture Material

  Class II

  FDA 510(k) K923161 Active Cleared 30 Dec 1992

• Mitek Toggle Anchor(Tm)

  Class II

  FDA 510(k) K950070 Active Cleared 22 May 1995

• Absorbalbe Anchor

  Class II

  FDA 510(k) K944051 Active Cleared 2 Aug 1995

• Mitek Ligament Anchor

  Class II

  FDA 510(k) K926270 Active Cleared 22 Oct 1993

See all devices from Mitek Surgical Products, Inc. →

• What is the Mitek Absorbable Anchor used for?

  The Mitek Absorbable Anchor is a suture anchor designed for secure tissue reattachment during surgical procedures, specifically intended for orthopedic and soft tissue repair applications in gastroenterology and urology.

• Is the Mitek Absorbable Anchor single-use or reusable?

  The Mitek Absorbable Anchor is designed for single-use applications only and should not be reused on multiple patients to ensure safety and effectiveness.

• What sizes are available for the Mitek Absorbable Anchor?

  The Mitek Absorbable Anchor is supplied in various sizes to accommodate different surgical needs, though specific size measurements are not detailed in the provided information.

• How should the Mitek Absorbable Anchor be stored?

  The Mitek Absorbable Anchor should be stored according to the manufacturer's instructions to maintain its integrity and effectiveness until use.

• What is the regulatory status of the Mitek Absorbable Anchor?

  The Mitek Absorbable Anchor is regulated under FDA 510(k) clearance with product code MNV, classified as substantially equivalent for some indications, and is not MRI compatible.