Product code KAK
- Device name
- Probe, Ent
- 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 |
|---|---|---|---|
| K822277 | ROSEN'S STAPES NEEDLE EXPLORER | Kelleher Corp. | 1982-08-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09348811115829 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-04-24 |
| 09348811005106 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
| 09348811112149 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 09348811150448 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| 10381780539407 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780540458 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780538509 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| M6335801010 | JEDMED | JEDMED INSTRUMENT COMPANY | 2023-01-19 |
| M6335801000 | JEDMED | JEDMED INSTRUMENT COMPANY | 2023-01-19 |
| 10840199516787 | Ball Probe | KOROS U.S.A., INC. | 2021-10-01 |
| 10840199516770 | Ball Probe | KOROS U.S.A., INC. | 2021-10-01 |
| 10840199516763 | Exploration Ball Probe Set | KOROS U.S.A., INC. | 2021-10-01 |
| 10840199516329 | McCulloch Style Ball Angled Probe | KOROS U.S.A., INC. | 2021-10-01 |
| 10840199516312 | McCulloch Style Ball Angled Probe | KOROS U.S.A., INC. | 2021-10-01 |
| 10840199516190 | Posterior Nerve Stimulator Probe | KOROS U.S.A., INC. | 2021-10-01 |
| 10840199507716 | Ball Probe | KOROS U.S.A., INC. | 2021-09-01 |
| 10840199507686 | Probe | KOROS U.S.A., INC. | 2021-09-01 |
| M6333814321 | ADEPT MEDICAL | JEDMED INSTRUMENT COMPANY | 2020-09-01 |
| M6333814351 | ADEPT MEDICAL | JEDMED INSTRUMENT COMPANY | 2020-09-01 |
| M6333814301 | ADEPT MEDICAL | JEDMED INSTRUMENT COMPANY | 2020-09-01 |
| 10381780490418 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 10381780402831 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780111559 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |
| 10381780110682 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |
| 10381780104780 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780103592 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780103608 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780103615 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780104797 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780419013 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |