Applicator, Ent
FDA product code KCJ · Class I (low risk) · 21 CFR 874.5220 · Ear, Nose, Throat
4510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923679 | Endopath Tissue Retaining ComponentKCJ · Traditional | Ethicon Endo-Surgery, Inc. | 09/09/1992SE |
| K921053 | Laparomed Ligating LoopKCJ · Traditional | Laparomed Corp. | 08/06/1992SE |
| K894369 | Apdyne Phenol Applicator KitKCJ · Traditional | Apdyne Medical Co. | 10/12/1989SESD |
| K832667 | Lucae's Ear & Nasal ApplicatorsKCJ · Traditional | Kells Medical, Inc. | 09/29/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1105-2025 Class II | NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL…Due to nasal spray stability failure for bioburden. | Neilmed Pharmaceuticals Inc | 12/28/2024Open, Classified |