FDA product code HQP: Unit, Cautery, Thermal, Battery-Powered
HQP is the FDA product code for unit, cautery, thermal, battery-powered. It is a Class II device, regulated under 21 CFR 886.4115 and reviewed by the Ophthalmic panel. FDA has cleared 24 510(k) submissions under HQP, from 13 different applicants. The average 510(k) review took 114 days (median 90). FDA has posted 3 recalls for HQP devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Cautery, Thermal, Battery-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4115 |
| 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 HQP clearance
Top HQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aaron Medical Industries | 4 | 1995-04-10 |
| Suncoast Medical Manufacturers, Inc. | 4 | 1984-05-09 |
| Medical Products Development, Inc. | 4 | 1981-04-23 |
| Starion Instruments | 3 | 2000-10-20 |
| Bovie Medical Corporation | 1 | 2012-07-20 |
8 more applicants have HQP clearances. See the full list in Caduvo.
Most recent HQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121441 | Bovie Medical Corporation | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | 2012-07-20 | 66 |
| K083428 | Fiab Spa | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | 2009-09-01 | 286 |
| K062659 | Kirwan Surgical Products, Inc. | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | 2007-03-09 | 183 |
| K023506 | Modern Medical Equipment Mfg., Ltd. | SURGICAL MEDICAL DEVICE CAUTERY | 2004-01-13 | 452 |
| K002547 | Starion Instruments | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | 2000-10-20 | 64 |
Recalls for HQP devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code HQP?
HQP is the FDA product code for unit, cautery, thermal, battery-powered. It is a Class II device, regulated under 21 CFR 886.4115 and reviewed by the Ophthalmic panel.
What device class is HQP?
Class II, regulation 21 CFR 886.4115. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQP?
Across 24 cleared submissions the average was 114 days from receipt to decision (median 90).
Which companies have the most HQP clearances?
Aaron Medical Industries (4); Suncoast Medical Manufacturers, Inc. (4); Medical Products Development, Inc. (4); Starion Instruments (3); Bovie Medical Corporation (1).
Have HQP devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2018-07-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HQP
- Run a recall and safety report across every HQP manufacturer
- Watch product code HQP 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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