Product code JYE
- Device name
- Chisel, Middle-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 |
|---|---|---|---|
| K822165 | ENT CHISELS | Kelleher Corp. | 1982-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00757770405220 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770409693 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770413140 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770417766 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770418695 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770424078 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-08 |
| 00757770676439 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-08-05 |
| 00888515230057 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515230040 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515230033 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515229099 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515229020 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515229013 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515228177 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515134157 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| 00888515230064 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-28 |
| G586E7214220 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586E7214730 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| 00190776319052 | Millennium | Avalign Technologies, Inc. | 2023-06-23 |
| 00840343716875 | GEN2 | SURGIX MEDICAL LLC | 2023-06-02 |
| 00840343716868 | GEN2 | SURGIX MEDICAL LLC | 2023-06-02 |
| 00840343716882 | GEN2 | SURGIX MEDICAL LLC | 2023-06-02 |
| 54026704805155 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704805157 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 00840343700607 | Gen2 | SURGIX MEDICAL LLC | 2022-10-18 |
| 10885403011627 | V. Mueller | STERIS CORPORATION | 2018-08-02 |
| 10885403011603 | V. Mueller | STERIS CORPORATION | 2018-08-02 |
| 10381780198581 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780107705 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |
| 10381780110620 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |