Product code JYJ
- Device name
- Gauge, Measuring
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4420
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904469 | EYEOPENER | Kc Medical Industries | 1991-06-28 |
| K884974 | ACCESSORY TO EYEDROP GUIDE | Suredrop, Inc. | 1989-03-24 |
| K874569 | SUREDROP EYEDROP GUIDE | Suredrop, Inc. | 1988-05-03 |
| K833606 | IMPLANT MEASURING GAUGE | Microtek Medical, Inc. | 1984-01-03 |
| K801938 | RHINOMETER | Aztec Medical Products, Inc. | 1980-09-09 |
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| 14250368865503 | AC Sizer System Total | Heinz Kurz GmbH | 2026-05-21 |
| 09348811109415 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-04-24 |
| 09348811109408 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-04-24 |
| 09348811109446 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
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| 00813307013075 | InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 2017-01-01 |