Product code JYL
- Device name
- Hook, Microsurgical Ear
- 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 |
|---|---|---|---|
| K834188 | JAKOBI SURG. INSTRUMENTS #7 10/43 | Imm Enterprises , Ltd. | 1984-03-06 |
| K822195 | MIRCOSURGICAL INSTRUMENTS | Kelleher Corp. | 1982-08-25 |
| K822166 | MICROSURGICAL EAR HOOK | Kelleher Corp. | 1982-08-20 |
| K780287 | DAY HEAR HOOK | Edward Weck, Inc. | 1978-02-27 |
| K772390 | DAY EAR HOOK | Edward Weck, Inc. | 1978-01-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840183512040 | BR Surgical, LLC | BR Surgical, LLC | 2024-06-03 |
| G043615030 | BEAR | Bear-Ent, LLC | 2022-06-12 |
| G043615020 | BEAR | Bear-Ent, LLC | 2022-06-12 |
| G043615010 | BEAR | Bear-Ent, LLC | 2022-06-12 |
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