HWI — Corkscrew Class I
FDA product code HWI covers "Corkscrew", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification details
- Product Code
- HWI
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- 510(k) Exempt
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K875166 | Baxter Healthcare | PHARMASEAL STERILE UMBILICAL CORD CLAMP | Mar 2, 1988 |