FDA product code HQW: Clip, Tantalum, Ophthalmic
HQW is the FDA product code for clip, tantalum, ophthalmic. It is a Class II device, regulated under 21 CFR 886.3100 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HQW, from 3 different applicants. The average 510(k) review took 60 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Tantalum, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.3100 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Compare with all 510(k) review times · Search every HQW clearance
Top HQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Grieshaber & Co. | 1 | 1990-04-12 |
| Alcon Surgical, Inc. | 1 | 1990-03-23 |
| Storz Instrument Co. | 1 | 1984-03-29 |
Most recent HQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K897119 | Grieshaber & Co. | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | 1990-04-12 | 107 |
| K901275 | Alcon Surgical, Inc. | RETINAL TAAK | 1990-03-23 | 4 |
| K840207 | Storz Instrument Co. | DOUBLE & SINGLE TANTALUM CLIPS | 1984-03-29 | 70 |
Recalls for HQW devices
openFDA lists no recalls for product code HQW.
Frequently asked questions
What is FDA product code HQW?
HQW is the FDA product code for clip, tantalum, ophthalmic. It is a Class II device, regulated under 21 CFR 886.3100 and reviewed by the Ophthalmic panel.
What device class is HQW?
Class II, regulation 21 CFR 886.3100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQW?
Across 3 cleared submissions the average was 60 days from receipt to decision (median 70).
Which companies have the most HQW clearances?
Grieshaber & Co. (1); Alcon Surgical, Inc. (1); Storz Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQW
- Run a recall and safety report across every HQW manufacturer
- Watch product code HQW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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