Product code MMO
- Device name
- Tray, Surgical, 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 |
|---|---|---|---|
| K771049 | ENDOSCOPIC TRAY | American Hospital Supply Corp. | 1977-09-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840217910057 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-10-08 |
| 00840217910040 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-10-08 |
| 00840217910033 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-10-08 |
| 04250407778262 | FENTEX | FENTEX medical GmbH | 2025-02-19 |
| 00840217909402 | Ace Medical Company | EBNER MEDICAL, LLC | 2024-12-11 |
| 00840217909396 | Ace Medical Company | EBNER MEDICAL, LLC | 2024-12-11 |
| 10198459084775 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-08-04 |
| 00840217908344 | Ace Medical Company | EBNER MEDICAL, LLC | 2023-08-23 |
| 00840217908351 | Wiggins Medical | EBNER MEDICAL, LLC | 2023-08-23 |
| 10193489451481 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-06-08 |
| 10193489451344 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-06-08 |
| 07630055505620 | OSSEOSTAP Sterilization Tray | Bien-Air Surgery SA | 2023-02-17 |
| 07630055505880 | PM2 Sterilization Tray ENT | Bien-Air Surgery SA | 2023-02-17 |
| 07630055505897 | PM2 Sterilization Tray Neuro | Bien-Air Surgery SA | 2023-02-17 |
| 10195327142902 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-06-10 |
| 00840217906135 | Wiggins Medical | EBNER MEDICAL, LLC | 2022-01-13 |
| 00840217906128 | ACE Medical | EBNER MEDICAL, LLC | 2022-01-13 |
| 10193489306897 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-11-09 |
| 10193489290233 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-11-08 |
| 10193489335460 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-08-27 |
| 10193489340174 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-08-27 |
| 00840217905329 | ACE Medical | EBNER MEDICAL, LLC | 2021-06-09 |
| 00840217905336 | ACE Medical | EBNER MEDICAL, LLC | 2021-06-09 |
| 00840217903424 | ACE Medical Company | EBNER MEDICAL, LLC | 2021-03-30 |
| 10381780490319 | MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 10381780490401 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 10381780490418 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 10381780490425 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 10381780490449 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 10381780490456 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |