Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3100](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3100) → HQW — Clip, Tantalum, Ophthalmic

# HQW · Clip, Tantalum, Ophthalmic

_Ophthalmic · 21 CFR 886.3100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW

## Overview

- **Product Code:** HQW
- **Device Name:** Clip, Tantalum, Ophthalmic
- **Regulation:** [21 CFR 886.3100](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3100)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K897119](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW/K897119.md) | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | Grieshaber & Co. | Apr 12, 1990 | SESE |
| [K901275](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW/K901275.md) | RETINAL TAAK | Alcon Surgical, Inc. | Mar 23, 1990 | SESE |
| [K840207](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW/K840207.md) | DOUBLE & SINGLE TANTALUM CLIPS | Storz Instrument Co. | Mar 29, 1984 | SESE |

## Top Applicants

- Alcon Surgical, Inc. — 1 clearance
- Grieshaber & Co. — 1 clearance
- Storz Instrument Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW)

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