FDA product code HWB: Extractor
HWB is the FDA product code for extractor. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under HWB, from 5 different applicants. The average 510(k) review took 24 days (median 10). FDA has posted 4 recalls for HWB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Extractor |
| 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 HWB clearance
Top HWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthropedics, Inc. | 1 | 1987-11-02 |
| Warsaw Orthopedic, Inc. | 1 | 1987-03-13 |
| Terray Manufacturing, Inc. | 1 | 1987-02-26 |
| The Anspach Effort, Inc. | 1 | 1980-06-09 |
| Richard'S Medical Equip., Inc. | 1 | 1978-02-28 |
Most recent HWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873710 | Arthropedics, Inc. | MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 | 1987-11-02 | 48 |
| K870844 | Warsaw Orthopedic, Inc. | SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR | 1987-03-13 | 10 |
| K870083 | Terray Manufacturing, Inc. | FERRAY EXTRACTOR | 1987-02-26 | 49 |
| K801327 | The Anspach Effort, Inc. | THE EXTRACTOR I TM | 1980-06-09 | 6 |
| K780300 | Richard'S Medical Equip., Inc. | HIP PLATE REMOVAL INSTRUMENT | 1978-02-28 | 6 |
Recalls for HWB devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2024-03-07.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HWB?
HWB is the FDA product code for extractor. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWB?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWB?
Across 5 cleared submissions the average was 24 days from receipt to decision (median 10).
Which companies have the most HWB clearances?
Arthropedics, Inc. (1); Warsaw Orthopedic, Inc. (1); Terray Manufacturing, Inc. (1); The Anspach Effort, Inc. (1); Richard'S Medical Equip., Inc. (1).
Have HWB devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-03-07.
Next steps
- Run an FDA pathway report with predicate devices for product code HWB
- Run a recall and safety report across every HWB manufacturer
- Watch product code HWB 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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