KHJ
- Product code
- KHJ
- Device name
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3620
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260266 | 2026-08-18 | Grace Medical, Inc. | Tympendi (810) | |
| K232646 | 2024-05-24 | Cook Biotech Incorporated | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4… |
Official FDA classification page: KHJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).