FDA product code HWI: Corkscrew
HWI is the FDA product code for corkscrew. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under HWI. The average 510(k) review took 76 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Corkscrew |
| 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 HWI clearance
Top HWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 1 | 1988-03-02 |
Most recent HWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875166 | Baxter Healthcare Corp | PHARMASEAL STERILE UMBILICAL CORD CLAMP | 1988-03-02 | 76 |
Recalls for HWI devices
openFDA lists no recalls for product code HWI.
Frequently asked questions
What is FDA product code HWI?
HWI is the FDA product code for corkscrew. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWI?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWI?
Across 1 cleared submissions the average was 76 days from receipt to decision (median 76).
Which companies have the most HWI clearances?
Baxter Healthcare Corp (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HWI
- Run a recall and safety report across every HWI manufacturer
- Watch product code HWI 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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