KHJ

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

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)

Last three years. Most recent: 2026-08-18.

NumberDecision dateApplicantDevice nameSummary
K2602662026-08-18Grace Medical, Inc.Tympendi™ (810)PDF
K2326462024-05-24Cook Biotech IncorporatedBiodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4…PDF

2 summaries are archived here for direct download.

Official FDA classification page: KHJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).