Product code EME
- Device name
- Punch, Biopsy, Surgical
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10649111226762 | Sklar Instruments | SKLAR CORPORATION | 2025-11-12 |
| 10649111226458 | Sklar Instruments | SKLAR CORPORATION | 2025-11-12 |
| 10649111226281 | Sklar Instruments | SKLAR CORPORATION | 2025-11-12 |
| 10649111225369 | Sklar Instruments | SKLAR CORPORATION | 2025-11-12 |
| 10649111087431 | Sklar Instruments | SKLAR CORPORATION | 2025-11-12 |
| 10649111082726 | Sklar Instruments | SKLAR CORPORATION | 2025-11-07 |
| 10649111072949 | Sklar Instruments | SKLAR CORPORATION | 2025-11-06 |
| 10080196030637 | Medline | MEDLINE INDUSTRIES, INC. | 2024-10-01 |
| 10080196030316 | Medline | MEDLINE INDUSTRIES, INC. | 2024-10-01 |
| 10080196029211 | Medline | MEDLINE INDUSTRIES, INC. | 2024-10-01 |
| 10080196029136 | Medline | MEDLINE INDUSTRIES, INC. | 2024-10-01 |
| 10080196025749 | Medline | MEDLINE INDUSTRIES, INC. | 2024-09-30 |
| 10080196029099 | Medline | MEDLINE INDUSTRIES, INC. | 2024-09-30 |
| 10080196028993 | Medline | MEDLINE INDUSTRIES, INC. | 2024-09-30 |
| 10080196024940 | Medline | MEDLINE INDUSTRIES, INC. | 2024-09-27 |
| 10080196028917 | Medline | MEDLINE INDUSTRIES, INC. | 2024-09-27 |
| 10080196024858 | Medline | MEDLINE INDUSTRIES, INC. | 2024-09-27 |
| GYNX13281 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX13261 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX1325 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX13241 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX13231 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX13221 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX13101 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| 08056646504770 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |
| 08056646504879 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |
| 08056646504855 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |
| 08056646504831 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |
| 08056646504817 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |
| 08056646504794 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |