← Product Code [HQW](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW) · K897119

# GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP (K897119)

_Grieshaber & Co. · HQW · Apr 12, 1990 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW/K897119

## Device Facts

- **Applicant:** Grieshaber & Co.
- **Product Code:** [HQW](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW.md)
- **Decision Date:** Apr 12, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3100
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## 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.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW/K897119](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQW/K897119)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com