Product code JYO
- Device name
- Knife, 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 |
|---|---|---|---|
| K910212 | COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST | Acoustic Imaging Technologies Corp. | 1991-07-11 |
| K841006 | EAR KNIFE-VARIOUS | Premier Dental Products Co. | 1984-05-30 |
| K840764 | EAR KNIVES | Sharpoint, Inc. | 1984-05-21 |
| K833602 | ROLLER KNIFE-TRANSVERSE -SAGITTAL | Microtek Medical, Inc. | 1984-01-03 |
| K823911 | KNIFE BLADE TIP | Treace Medical, Inc. | 1983-01-21 |
| K772372 | ROLLER KNIFE | Edward Weck, Inc. | 1978-01-17 |
| K772384 | MYRINGOTOMY KNIFE | Edward Weck, Inc. | 1978-01-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09348811150233 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-04-10 |
| 09348811108869 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811108913 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109040 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109057 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109064 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109071 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109088 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109095 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109170 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811109187 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| 09348811149909 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-23 |
| G043659000 | BEAR | Bear-Ent, LLC | 2023-07-26 |
| G043659080 | BEAR | Bear-Ent, LLC | 2023-07-26 |
| G043659090 | BEAR | Bear-Ent, LLC | 2023-07-26 |
| G043659020 | BEAR | Bear-Ent, LLC | 2022-08-10 |
| G043659030 | BEAR | Bear-Ent, LLC | 2022-08-10 |
| 10190660197947 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660197718 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197725 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197886 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197893 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197909 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197916 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197923 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197930 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197954 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660197961 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198128 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660198197 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |