FDA product code HWJ: Awl
HWJ is the FDA product code for awl. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under HWJ, from 3 different applicants. The average 510(k) review took 55 days (median 50). FDA has posted 26 recalls for HWJ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Awl |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWJ clearance
Top HWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Buckman Co., Inc. | 2 | 1988-02-17 |
| Cross Medical Products, Inc. | 1 | 1990-01-04 |
| Danninger Medical Technology, Inc. | 1 | 1988-02-17 |
Most recent HWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895587 | Cross Medical Products, Inc. | CROSS MEDICAL PRODUCT PEDICLE AWL | 1990-01-04 | 111 |
| K880045 | Buckman Co., Inc. | ACROMED AWL/PUNCH, DEPTH GAUGE | 1988-02-17 | 42 |
| K875223 | Danninger Medical Technology, Inc. | DANNINGER ORTHOPAEDIC AWL | 1988-02-17 | 57 |
| K870779 | Buckman Co., Inc. | ACROMED WALLIE-HEINIG TROCHAR | 1987-03-09 | 11 |
Recalls for HWJ devices
26 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-06-04.
| Year | Recalls |
|---|---|
| 2020 | 24 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HWJ?
HWJ is the FDA product code for awl. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWJ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWJ?
Across 4 cleared submissions the average was 55 days from receipt to decision (median 50).
Which companies have the most HWJ clearances?
Buckman Co., Inc. (2); Cross Medical Products, Inc. (1); Danninger Medical Technology, Inc. (1).
Have HWJ devices been recalled?
Yes: 26 product recalls across 3 recall events; the most recent began 2024-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code HWJ
- Run a recall and safety report across every HWJ manufacturer
- Watch product code HWJ 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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