Product code FAX
- Device name
- Bougie, Urological
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5520
- Review panel
- GU
- 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 |
|---|---|---|---|
| 00810143905816 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905809 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905915 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905908 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905892 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905885 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905878 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905861 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905854 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905847 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905830 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143905823 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 10801334008086 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334008079 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007812 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007591 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007447 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007225 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007218 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007201 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007195 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007188 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007171 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007164 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334001162 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334001063 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334000868 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334000851 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334000844 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334000240 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |