FDA product code HWW: Countersink
HWW is the FDA product code for countersink. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. Devices under HWW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 17 recalls for HWW devices.
Classification
| Field | Value |
|---|---|
| Device name | Countersink |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for HWW devices
17 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-08.
| Year | Recalls |
|---|---|
| 2019 | 16 |
Frequently asked questions
What is FDA product code HWW?
HWW is the FDA product code for countersink. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWW?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
Have HWW devices been recalled?
Yes: 17 product recalls across 2 recall events; the most recent began 2019-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code HWW
- Run a recall and safety report across every HWW manufacturer
- Watch product code HWW 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times