Applicator, Ent
An ENT applicator is a simple instrument used to apply medications, topical agents, or dressings to surfaces within the ear, nose, or throat, such as cotton-tipped or swab-type devices used to deliver antiseptics, anesthetics, or other preparations. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KCJ is regulated under 21 CFR 874.5220 in the Ear, Nose, Throat medical specialty. This device is GMP exempt, meaning it is not subject to the full FDA Quality System Regulation requirements.
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Basic Information
- Product Code
- KCJ
- Device Class
- FDA class 1
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K923679 | ENDOPATH TISSUE RETAINING COMPONENT | Sep 09, 1992 | Substantially Equivalent | Ethicon Endo-Surgery, Inc. |
| K921053 | LAPAROMED LIGATING LOOP | Aug 06, 1992 | Substantially Equivalent | Laparomed Corp. |
| K894369 | APDYNE PHENOL APPLICATOR KIT | Oct 12, 1989 | Unknown | Apdyne Medical Co. |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Sep 29, 1983 | Substantially Equivalent | Kells Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 134 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 134 registration numbers. Click on an entry to view related FDA registrations.