KCJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Applicator, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5220
- Medical specialty
- Ear, Nose, Throat
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ENDOPATH TISSUE RETAINING COMPONENT (K923679) | Ethicon Endo-Surgery, Inc. | 1992-09-09 |
| LAPAROMED LIGATING LOOP (K921053) | Laparomed Corp. | 1992-08-06 |
| APDYNE PHENOL APPLICATOR KIT (K894369) | Apdyne Medical Co. | 1989-10-12 |
| LUCAE'S EAR & NASAL APPLICATORS (K832667) | Kells Medical, Inc. | 1983-09-29 |
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Every clearance here is in the API, with alerts when new ones post.