FDA product code HXC: Wrench
HXC is the FDA product code for wrench. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under HXC, from 5 different applicants. The average 510(k) review took 36 days (median 31). FDA has posted 8 recalls for HXC devices.
Classification
| Field | Value |
|---|---|
| Device name | Wrench |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for HXC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 55 |
Compare with all 510(k) review times · Search every HXC clearance
Top HXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Tool, Inc. | 2 | 1987-11-23 |
| Gauthier Biomedical, Inc. | 1 | 2018-03-08 |
| Jerome Medical | 1 | 1987-03-11 |
| Twin City Surgical, Inc. | 1 | 1981-11-24 |
| Truth, Inc. | 1 | 1979-06-20 |
Most recent HXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180092 | Gauthier Biomedical, Inc. | Intellitorq | 2018-03-08 | 55 |
| K874358 | Med-Tool, Inc. | COMBINATION WRENCHES | 1987-11-23 | 31 |
| K874359 | Med-Tool, Inc. | ADJUSTABLE WRENCHES | 1987-11-23 | 31 |
| K870053 | Jerome Medical | TORQUEDRIVER WRENCH | 1987-03-11 | 63 |
| K813067 | Twin City Surgical, Inc. | SPINAL WRENCH | 1981-11-24 | 25 |
Recalls for HXC devices
8 product recalls in 7 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-08-14.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code HXC?
HXC is the FDA product code for wrench. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXC?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXC?
Across 6 cleared submissions the average was 36 days from receipt to decision (median 31).
Which companies have the most HXC clearances?
Med-Tool, Inc. (2); Gauthier Biomedical, Inc. (1); Jerome Medical (1); Twin City Surgical, Inc. (1); Truth, Inc. (1).
Have HXC devices been recalled?
Yes: 8 product recalls across 7 recall events; the most recent began 2019-08-14.
Next steps
- Run an FDA pathway report with predicate devices for product code HXC
- Run a recall and safety report across every HXC manufacturer
- Watch product code HXC 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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