FDA product code HQQ: Apparatus, Cautery, Radiofrequency, Battery-Powered
HQQ is the FDA product code for apparatus, cautery, radiofrequency, battery-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HQQ, from 2 different applicants. The average 510(k) review took 76 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Cautery, Radiofrequency, Battery-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4100 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HQQ clearance
Top HQQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mentor O & O, Inc. | 2 | 1990-11-05 |
| Scitech Industries Partnership | 1 | 1991-04-08 |
Most recent HQQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910088 | Scitech Industries Partnership | SCITECH BI-MANUAL ADAPTER CLIPS | 1991-04-08 | 89 |
| K903878 | Mentor O & O, Inc. | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | 1990-11-05 | 75 |
| K881001 | Mentor O & O, Inc. | MENTOR WET-FIELD*II COAGULATOR | 1988-05-13 | 65 |
Recalls for HQQ devices
openFDA lists no recalls for product code HQQ.
Frequently asked questions
What is FDA product code HQQ?
HQQ is the FDA product code for apparatus, cautery, radiofrequency, battery-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel.
What device class is HQQ?
Class II, regulation 21 CFR 886.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQQ?
Across 3 cleared submissions the average was 76 days from receipt to decision (median 75).
Which companies have the most HQQ clearances?
Mentor O & O, Inc. (2); Scitech Industries Partnership (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQQ
- Run a recall and safety report across every HQQ manufacturer
- Watch product code HQQ 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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