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Anchor Band Suturing System, Model SR-AB

by Anulex Technologies, Inc.

510(k) K061386

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061386 Date5 Jul 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAT
Device Class
Class II
Regulation
21 CFR Part 878.5000
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Anchor Band Suturing System is a medical device designed for soft tissue approximation in surgical procedures. It consists of a non-absorbable braided polyethylene terephthalate (PET) surgical suture and a T-anchor, which is preloaded on a disposable delivery instrument. The system is intended for use in general and orthopedic surgery.

The device is supplied sterile and is used by clinicians to place the T-anchor in the tissue sub-layer. It is a single-use device and is regulated under FDA 510(k) clearance. The Anchor Band Suturing System, Model SR-AB, is indicated for soft tissue approximation in surgical applications.

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