Perforator, Ear-Lobe
Perforator, Ear-Lobe is a surgical or clinical instrument used to create a perforation in the ear lobe, either for cosmetic piercing in a medical setting or for small diagnostic or therapeutic procedures involving the ear lobe. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYS, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JYS
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860622 | STUDEX EAR PIERCING GUNS | Oct 17, 1986 | Substantially Equivalent | Onyx Industries, Inc. |
| K860678 | J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS | Aug 29, 1986 | Substantially Equivalent | Jay Kenny Templeton |
| K772171 | EAR PIERCING DEVICE | Jan 03, 1978 | Substantially Equivalent | Robert C. Cameron |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.