QCW — Corneal Storage Media With Preservatives Including Anti-Fungal Class II
FDA product code QCW covers "Corneal Storage Media With Preservatives Including Anti-Fungal", a Class II medical device regulated under 21 CFR 886.4320. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QCW
- Device Class
- Class II
- Regulation Number
- 886.4320
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Media to preserve human corneas while in storage.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200063 | al.chi.mi.a | Kerasave | May 2, 2022 |