Product code FFS
- Device name
- Image, Illumination, Fiberoptic, For Endoscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Cook Urological, Inc. | 2007-11-20 |
| K061622 | PS SERIES | Photonic Optische Gerate Gesmbh & Cokg | 2007-03-05 |
| K063309 | TRU-CABLE | Truphatek International, Ltd. | 2007-01-12 |
| K061025 | ACCUTECH ENDOLITE PROBE | Accutech Medical Technologies, Inc. | 2006-05-31 |
| K023633 | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | Sovis Optique | 2002-12-31 |
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | Cogent Light Technologies, Inc. | 2000-07-17 |
| K994084 | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES | Smith & Nephew, Inc. | 2000-01-20 |
| K991323 | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR | Smith & Nephew, Inc. | 1999-07-06 |
| K983714 | SOLARTEC SOURCE 270, MODEL # 90123 | Cogent Light Technologies, Inc. | 1998-12-23 |
| K982462 | FIBER OPTIC ENDOILLUMINATION PROBE | Microvision, Inc. | 1998-09-14 |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | Dutch Ophthalmic USA, Inc. | 1998-05-20 |
| K970217 | VISTA ILLUMINATION SYSTEM | Vista Medical Technologies, Inc. | 1997-04-02 |
| K962595 | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS | KARL STORZ Endoscopy-America, Inc. | 1996-09-04 |
| K950960 | REDDY ILLUMINATOR | Luxtec Corp. | 1995-09-08 |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | Alm Surgical Equipment, Inc. | 1994-11-04 |
| K944688 | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1994-11-01 |
| K940963 | XENON LIGHT SOURCE | Incredivision, Inc. | 1994-04-08 |
| K940962 | LIQUID LIGHT 500 | Incredivision, Inc. | 1994-04-08 |
| K933216 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ Endoscopy-America, Inc. | 1993-09-09 |
| K892145 | FIBER OPTIC LIGHT TRANSMISSION CABLE | Opto Vision, Inc. | 1989-09-29 |
| K893440 | FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 | Welch Allyn, Inc. | 1989-07-28 |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | Mira, Inc. | 1989-05-08 |
| K844773 | EFF-EFFNER BULBS | Mecron Medical Products, Inc. | 1985-01-08 |
| K834576 | REAL FIBER OPTIC URETERAL TRANSILLUMIN | Douglas Manufacturer Co. | 1984-04-20 |
| K840605 | LABORIE FIBREOPTIC LIGHT CABLE | Tridak Division of Indicon, Inc. | 1984-04-13 |
| K834487 | FLEXIBLE LIQUID LIGHT GUIDE | Endo Lase, Inc. | 1984-02-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B382SD77321140 | Surgical Direct | Surgical Direct, Inc. | 2026-02-03 |
| B382SD512531140 | Surgical Direct | Surgical Direct, Inc. | 2026-02-03 |
| 00857580006829 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2025-02-26 |
| 00857580006812 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2024-10-15 |
| 00857580006799 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2023-03-06 |
| 00857580006782 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2023-03-06 |
| 00851925007731 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00851925007762 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00851925007755 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00851925007748 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00851925007724 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00851925007717 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00851925007700 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| 00857580006768 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2021-03-18 |
| 00857580006706 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2018-09-20 |
| 00857580006690 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2018-07-30 |
| 10818255010449 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010470 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010654 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010685 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010722 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010739 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010746 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010968 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255011040 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010166 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255011095 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255011163 | NA | MICROVISION, INC. | 2018-01-17 |
| 00857580006676 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2018-01-04 |
| 00857580006652 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2017-10-18 |