Gauge, Measuring
Gauge, Measuring is a surgical measuring instrument used to assess dimensions or distances within the ear or middle ear cavity during ENT surgical procedures, supporting accurate sizing of implants or prostheses to be placed. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYJ, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JYJ
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904469 | EYEOPENER | Jun 28, 1991 | Substantially Equivalent | Kc Medical Industries |
| K884974 | ACCESSORY TO EYEDROP GUIDE | Mar 24, 1989 | Substantially Equivalent | Suredrop, Inc. |
| K874569 | SUREDROP EYEDROP GUIDE | May 03, 1988 | Substantially Equivalent | Suredrop, Inc. |
| K833606 | IMPLANT MEASURING GAUGE | Jan 03, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K801938 | RHINOMETER | Sep 09, 1980 | Substantially Equivalent | Aztec Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.