Product code FDG
- Device name
- Retractor, Fiberoptic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.4530
- 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 |
|---|---|---|---|
| G14157204210 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G14157210130 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G14157210200 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G141572103590 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G14157210570 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G14157210590 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G14157210670 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G141572107270 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G14157210830 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G1415543110400 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| 00840329838867 | N/A | BLACK & BLACK SURGICAL, INC. | 2026-09-29 |
| G425110686LSI0 | My Medical | My Medical Store LLC | 2026-05-04 |
| G425110676LSI0 | My Medical | My Medical Store LLC | 2026-05-04 |
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| G14157210810 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2023-02-13 |
| 00840329805982 | N/A | BLACK & BLACK SURGICAL, INC. | 2022-09-21 |
| 00840329806033 | N/A | BLACK & BLACK SURGICAL, INC. | 2022-09-21 |
| 00840329813369 | N/A | BLACK & BLACK SURGICAL, INC. | 2022-09-21 |
| 00840329813376 | N/A | BLACK & BLACK SURGICAL, INC. | 2022-09-21 |
| 00840329813512 | N/A | BLACK & BLACK SURGICAL, INC. | 2022-09-21 |
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| 00843210144184 | Altus Spine Bifurcated Illuminator | Lumitex, Inc. | 2020-09-28 |
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| 10705034714523 | NA | Synthes GmbH | 2018-10-12 |
| 10705034715247 | NA | Synthes GmbH | 2018-10-12 |
| 10705034714530 | NA | Synthes GmbH | 2016-12-31 |
| 10705034725703 | NA | Synthes GmbH | 2016-12-31 |