Curette, Ear
Curette, Ear is a small spoon-shaped surgical instrument used to remove cerumen (earwax), debris, granulation tissue, or small lesions from the ear canal or middle ear under direct visualization or with the aid of an operating microscope. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYG, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JYG
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932609 | EAR CURETTE | Jul 21, 1993 | Substantially Equivalent | Ear Tech, Inc. |
| K852039 | FLEX-LOOP FLEXIBLE EAR CORETTE | Jun 11, 1985 | Substantially Equivalent | Bionix Corp. |
| K841354 | CURETTE | Jul 06, 1984 | Substantially Equivalent | Treace Medical, Inc. |
| K841001 | EAR CURETTE, VARIOUS | May 29, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K823916 | WAX CURETTE TIP | Jan 21, 1983 | Substantially Equivalent | Treace Medical, Inc. |
| K822273 | ENT CURRETTES | Aug 30, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822006 | OPERATIVE EAR CURRETTES & RELATED ITEM | Aug 12, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 148 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 148 registration numbers. Click on an entry to view related FDA registrations.