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 |
|---|---|---|---|
| G425110676LSI0 | My Medical | My Medical Store LLC | 2026-05-04 |
| G425110686LSI0 | My Medical | My Medical Store LLC | 2026-05-04 |
| 00812432023157 | Medtronic Surgical Illuminator - Blade | Lumitex, Inc. | 2026-04-17 |
| 00812432023140 | Medtronic Surgical Illuminator - Tube | Lumitex, Inc. | 2026-04-17 |
| 00888515319431 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-21 |
| 00888515319424 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-21 |
| 00888515319417 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-21 |
| 00888515319363 | BOSS Instruments | BOSS INSTRUMENTS, LTD., INC. | 2024-02-21 |
| G14157210810 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2023-02-13 |
| 00812432022914 | DePuy TSS Retractor Light Strip 5-Pack | Lumitex, Inc. | 2022-05-31 |
| 10885403285356 | Snowden-Pencer | STERIS CORPORATION | 2021-03-29 |
| 10885403285363 | Snowden-Pencer | STERIS CORPORATION | 2021-03-29 |
| 10885403285370 | Snowden-Pencer | STERIS CORPORATION | 2021-03-29 |
| 07630040712606 | Spine Instruments | Medacta International SA | 2020-12-09 |
| 00812432021535 | Novus N-Sight Disposable Surgical Light | Lumitex, Inc. | 2020-09-30 |
| 00812432020088 | Boss Instruments LightMat Surgical Illuminator | Lumitex, Inc. | 2019-10-28 |
| 00869836000321 | Fiber Optic Illuminator | I-Tek Medical, Inc. | 2019-05-28 |
| 00869836000314 | Fiber Optic Illuminator | I-Tek Medical, Inc. | 2018-12-06 |
| 10705034726724 | ORACLE | Synthes GmbH | 2018-10-12 |
| 10705034715247 | NA | Synthes GmbH | 2018-10-12 |
| 10705034714523 | NA | Synthes GmbH | 2018-10-12 |
| 10705034731100 | NA | Synthes GmbH | 2018-10-12 |
| 00816734021286 | InnerVision® | DIVERSATEK HEALTHCARE, INC. | 2018-09-18 |
| 24026704411027 | PILLING | TELEFLEX INCORPORATED | 2018-09-15 |
| 24026704411034 | PILLING | TELEFLEX INCORPORATED | 2018-09-15 |
| 24026704411041 | PILLING | TELEFLEX INCORPORATED | 2018-09-15 |
| 10885403151354 | Snowden-Pencer | CAREFUSION 2200, INC | 2018-07-12 |
| 00851797006504 | TSI | TEDAN SURGICAL INNOVATIONS, L.L.C. | 2017-05-22 |
| 10705034725703 | NA | Synthes GmbH | 2016-12-31 |
| 10705034714530 | NA | Synthes GmbH | 2016-12-31 |