Skip to content

Grieshaber Retinal Tack and Sutherland Tack Forcep

by Grieshaber & Co.

510(k) K897119

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 NumberK897119 Date12 Apr 1990ClearedStatusActive

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  • Withdrawn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
HQW
Device Class
Class II
Regulation
21 CFR Part 886.3100
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Grieshaber Retinal Tack and Sutherland Tack Forceps are ophthalmic surgical instruments designed for retinal fixation. These forceps are used to apply tantalum retinal tacks, which secure the retina in place during retinal detachment repair procedures. The device includes both the tacks and the forceps required to position them accurately within the eye. Tantalum tacks are biocompatible and provide mechanical stabilization to the retinal tissue.

These forceps are intended for single-use in sterile surgical settings, adhering to ophthalmic surgical standards. The device is classified under FDA Class II (HQW product code) and holds an FDA 510(k) clearance (K897119) for substantial equivalence. The forceps are supplied sterile and must be handled in accordance with aseptic techniques. No MRI safety information is specified, and the device is not reusable. Storage should follow manufacturer guidelines to maintain sterility and functionality.

Other devices from Grieshaber & Co.

See all devices from Grieshaber & Co. →

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Grieshaber Retinal Tack and Sutherland Tack Forceps used for?

    This device is specifically designed for retinal detachment repair procedures. The forceps apply tantalum retinal tacks, which provide mechanical stabilization to the retina by securing it in place. The biocompatible tantalum tacks ensure the retina remains properly positioned during healing.

  • Are the forceps and tacks supplied sterile, and how should they be handled?

    Yes, the Grieshaber Retinal Tack and Sutherland Tack Forceps are supplied sterile. They must be handled using aseptic techniques to maintain sterility, as required for surgical settings. Improper handling could compromise the device’s integrity and patient safety.

  • Can the Grieshaber Retinal Tack and Sutherland Tack Forceps be reused?

    No, these forceps are intended for single-use only. Reuse is not recommended due to the risk of contamination and potential damage to the instrument, which could affect precision and patient outcomes during retinal surgery.

  • What materials are the retinal tacks made of, and why is this important?

    The retinal tacks are made of tantalum, a biocompatible material. This is important because it minimizes the risk of adverse tissue reactions, ensuring the tacks integrate well with retinal tissue while providing stable fixation during the healing process.

  • How should the device be stored to maintain its functionality?

    Storage should follow the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping the device in its original packaging, away from moisture, extreme temperatures, and direct light, until ready for use in a sterile surgical environment.