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Retinal Taak Clip, Tantalum

by Alcon Surgical, Inc.

510(k) K901275

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 NumberK901275 Date23 Mar 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  • Withdrawn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)

Full name
Retinal Taak
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, 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 Retinal Taak Clip, Tantalum is an ophthalmic device classified as a Tantalum Clip under the FDA’s nomenclature. It is designed for retinal attachment procedures, providing secure fixation to stabilize retinal tissue during surgical interventions. Constructed from tantalum—a biocompatible metal—it ensures durability and minimal tissue reaction while facilitating precise placement within the eye.

This device is supplied sterile and intended for single-use in ophthalmic surgical settings. It is classified under FDA product code HQW and falls under Class II regulatory requirements. The Retinal Taak Clip is intended for use in procedures requiring retinal reattachment, with no specific MRI safety restrictions noted. Storage should follow sterile medical device protocols to maintain integrity until use.

Other devices from Alcon Surgical, Inc.

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 is the Retinal Taak Clip primarily used for in ophthalmic surgery?

    The Retinal Taak Clip is designed specifically for retinal attachment procedures to provide secure fixation and stabilize retinal tissue during surgery. Its biocompatible tantalum construction ensures durability and minimizes tissue reaction, making it ideal for stabilizing the retina when precise placement is critical.

  • Is the Retinal Taak Clip reusable, or is it meant for single-use only?

    The Retinal Taak Clip is explicitly intended for single-use in ophthalmic surgical settings. This ensures sterility and reduces the risk of contamination or cross-infection, which is particularly important in delicate eye procedures.

  • How should the Retinal Taak Clip be stored before use to maintain its integrity?

    The device must be stored following standard sterile medical device protocols to preserve its sterility and structural integrity. Since it is supplied sterile, proper packaging and environmental controls are essential to prevent compromise before surgical use.

  • What material is the Retinal Taak Clip made from, and why is this important?

    The Retinal Taak Clip is constructed from tantalum, a biocompatible metal known for its durability and minimal tissue reaction. This material choice ensures the clip remains stable within the eye while reducing the risk of adverse reactions, which is critical for long-term retinal fixation.

  • Are there any special handling or safety considerations for the Retinal Taak Clip during or after surgery?

    While no specific MRI safety restrictions are noted for the Retinal Taak Clip, its use is confined to retinal reattachment procedures. Since it is a single-use device, proper disposal after surgery is required to avoid reuse, which could compromise sterility and patient safety.