Product code GCC
- Device name
- Dilator, Catheter
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- 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 |
|---|---|---|---|
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | Med Institute, Inc. | 1998-05-26 |
| K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | Med Institute, Inc. | 1992-07-30 |
| K902502 | BYRD STAINLESS STEEL DILATOR | Medical Engineering and Development Institute | 1990-08-07 |
| K893480 | BYRD EXTRACTOR SET | Medical Engineering and Development Institute | 1989-06-23 |
| K820865 | VAN-TEC FASCIAL DILATOR | Van-Tec, Inc. | 1982-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810212930411 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930404 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933566 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933559 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933542 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933535 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933528 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933511 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933504 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930459 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930442 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930435 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930428 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 06936881156755 | Percutaneous Nephrostomy Dilator | Well Lead Medical Co.,Ltd | 2022-12-08 |
| 06936881156748 | Percutaneous Nephrostomy Dilator | Well Lead Medical Co.,Ltd | 2022-12-08 |
| 06936881156731 | Percutaneous Nephrostomy Dilator | Well Lead Medical Co.,Ltd | 2022-12-08 |
| 06936881156724 | Percutaneous Nephrostomy Dilator | Well Lead Medical Co.,Ltd | 2022-12-08 |
| 07613327459203 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 07613327459197 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 07613327459180 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 08714729295860 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-19 |
| 08714729295884 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-19 |
| 08714729295846 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-19 |
| 00886333004904 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333004911 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333004928 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333004935 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333004942 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333004959 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |
| 00886333004966 | Screw Dilator | ARGON MEDICAL DEVICES, INC. | 2016-09-12 |