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 |
|---|---|---|---|
| 05060411987586 | Oral Biopsy Punch Long 180 mm | DTR MEDICAL LIMITED | 2026-06-12 |
| 05060411987579 | Oral Rotating Biopsy Punch 120 mm | DTR MEDICAL LIMITED | 2026-06-12 |
| 05060212051073 | Oral Biopsy Forceps Long 120mm | DTR MEDICAL LIMITED | 2026-06-11 |
| 05060212051066 | Oral Biopsy Forceps 90mm | DTR MEDICAL LIMITED | 2026-06-11 |
| 05060411987401 | Oral Biopsy Forceps Long 180 mm | DTR MEDICAL LIMITED | 2024-10-14 |
| 05060411987388 | Oral Rotating Biopsy Forceps 120 mm | DTR MEDICAL LIMITED | 2024-10-14 |
| 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 |
| 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 |
| 08056646504770 | Punches, NOBEL | OMNIA SRL | 2021-08-09 |
| 00814105020883 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020982 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020890 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020906 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020913 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020920 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020937 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020944 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020951 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020968 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020975 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105021019 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105021002 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |
| 00814105020999 | Acu-Punch | ACUDERM, INC. | 2020-09-22 |