Syringe, Ent
An ENT syringe is a device used to irrigate, lavage, or deliver fluids to the ear canal, nasal passages, or throat, typically for the removal of cerumen, foreign bodies, or to administer topical treatments. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KCP 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 full Quality System Regulation requirements.
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Basic Information
- Product Code
- KCP
- 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 |
|---|---|---|---|---|
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | May 09, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K822754 | EAR/ULCER SYRINGE | Oct 04, 1982 | Substantially Equivalent | American Hospital Supply Corp. |
| K810284 | AUTOMATIC TEFLON INJECTION SYRINGE | Mar 11, 1981 | Substantially Equivalent | R. Wolf Medical Instruments Corp. |
| K780599 | SYRINGE, EAR & ULCER | Apr 19, 1978 | Substantially Equivalent | Abco Dealers, Inc. |
FEI Numbers
This FDA classification entry is associated with 140 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 140 registration numbers. Click on an entry to view related FDA registrations.