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EasyTac Anchor. EasyTac Delivery System

by Medchannel, LLC

510(k) K060494

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 NumberK060494 Date3 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  • Withdrawn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
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 EasyTac Anchor. EasyTac Delivery System is an implantable staple device designed for soft tissue approximation and mesh fixation. It comprises a disposable delivery instrument and resorbable fixation devices, enabling secure attachment during surgical procedures.

This system is used in endoscopic or open surgical settings and includes a reusable delivery instrument with an ergonomic handle, trigger mechanism, rotation knob, and a shaft containing 5–15 fixation devices. The instrument is single-use, and the fixation devices are resorbable. No MRI safety or sterility specifications are noted in the regulatory data. Authorised under FDA 510(k) clearance (K060494), it falls under classification GDW (Staple, Implantable) and regulation 878.4750.

Other devices from Medchannel, LLC

Questions

AI-generated answers, 20 Sep 2026

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

  • What types of surgical procedures is the EasyTac Anchor. EasyTac Delivery System designed for, and how does it differ from traditional staples?

    The EasyTac Anchor. EasyTac Delivery System is designed for soft tissue approximation and mesh fixation in both endoscopic and open surgical settings. Unlike traditional staples, it uses resorbable fixation devices delivered via a disposable instrument, which eliminates the need for removal after healing. The system’s ergonomic handle and trigger mechanism are intended to improve precision and ease of use during procedures.

  • Is the EasyTac Delivery System reusable, and if not, what does that mean for my workflow?

    The EasyTac Delivery System’s instrument is single-use, meaning each device must be discarded after one use to maintain sterility and functionality. However, the resorbable fixation devices themselves are designed to be implanted and absorbed by the body over time, so they do not require removal. This setup ensures a clean workflow—no reprocessing of the instrument is needed, but you’ll need to account for single-use instrument disposal in your OR logistics.

  • How many fixation devices are included in each EasyTac Delivery System, and can I choose the quantity?

    Each EasyTac Delivery System instrument contains 5 to 15 fixation devices preloaded in its shaft, depending on the specific model. The quantity is not user-selectable—it’s determined by the instrument’s configuration. You’ll need to verify the exact count for your procedure by checking the packaging or consulting Medchannel’s product specifications, as different models may vary.

  • Are there any special handling or storage requirements for the EasyTac Anchor. EasyTac Delivery System before use?

    The regulatory data does not specify sterility or MRI safety details for the EasyTac Anchor. However, as a single-use surgical instrument, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow Medchannel’s provided instructions for unpacking and preparation to ensure proper functionality before use. Always check expiration dates and packaging integrity.

  • What medical specialties commonly use the EasyTac Anchor. EasyTac Delivery System, and why might they prefer it?

    The system is primarily authorized for use in General Plastic Surgery, as indicated by its advisory committee and registration data. Surgeons in this field may prefer it for procedures requiring secure mesh fixation or soft tissue approximation, such as hernia repairs or reconstructive surgeries. Its resorbable design reduces the need for follow-up removals, which can streamline recovery and reduce patient discomfort.