Product code GDN
- Device name
- Knife, Amputation
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K851752 | 9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS | Artiberia | 1985-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B356BH414050 | American Medicals | American Medicals | 2026-05-06 |
| 24026704941647 | PILLING | TELEFLEX INCORPORATED | 2026-03-23 |
| 14026704941640 | PILLING | TELEFLEX INCORPORATED | 2026-03-23 |
| 24026704941654 | PILLING | TELEFLEX INCORPORATED | 2026-02-11 |
| 14026704941657 | PILLING | TELEFLEX INCORPORATED | 2026-02-11 |
| 08403207009500 | Anmuth Medical International | Anmuth Medical International, LLC | 2025-06-09 |
| 00840343725563 | GEN2 | SURGIX MEDICAL LLC | 2025-02-11 |
| B356EE173000 | American Medicals | American Medicals | 2024-11-12 |
| 04049197022644 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| 04049197022651 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| 04049197022668 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| 04049197022637 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| 04049197022613 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| 04049197022675 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| 04049197410540 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-21 |
| B356126CL120 | American Medicals | American Medicals | 2024-05-14 |
| G586N91281280 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586N91281310 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| B356BH432220 | American Medicals | American Medicals | 2022-09-16 |
| B356BH420130 | American Medicals | American Medicals | 2022-09-16 |
| 10649111392856 | Sklar® | SKLAR CORPORATION | 2018-11-26 |
| 10649111392849 | Sklar® | SKLAR CORPORATION | 2018-11-26 |
| 10649111281921 | Sklar® | SKLAR CORPORATION | 2018-11-26 |
| 10649111279812 | Sklar® | SKLAR CORPORATION | 2018-11-26 |
| 10885403203930 | V. Mueller | STERIS CORPORATION | 2018-09-10 |
| 10885403203947 | V. Mueller | STERIS CORPORATION | 2018-09-10 |
| 10381780457695 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-02 |
| 10381780183365 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-02 |
| 10381780426554 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-12 |
| 10381780426547 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-12 |