Product code EQH
- Device name
- Source, Carrier, Fiberoptic Light
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4350
- Review panel
- EN
- 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 |
|---|---|---|---|
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Wells Johnson Co. | 1995-12-04 |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | Jedmed Instrument Co. | 1995-11-13 |
| K951829 | COLD LIGHT SOURCE LOS 150 | Laser-Optik-Systeme GmbH & Co. KG | 1995-07-10 |
| K932771 | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | Xomed-Treace, Inc. | 1994-08-24 |
| K941661 | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT | Gm Engineering, Inc. | 1994-08-23 |
| K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT | Gm Engineering, Inc. | 1994-07-20 |
| K934911 | SAPHIRE PLUS SURGICAL MIRROR | San Diego Swiss Machining, Inc. | 1994-06-21 |
| K932131 | MID LABS TWIN ILLUMINATOR | Medical Instrument Development Laboratories, Inc. | 1994-04-01 |
| K930123 | ASPIRATING ENDO OCULAR PROBE | Surgical Technologies, Inc. | 1994-02-16 |
| K933145 | FIBEROPTIC LIGHTSOURCES AND CARRIERS | Electro Fiberoptics Corp. | 1993-09-07 |
| K923227 | THROAT-A-SCOPE | Truphatek, Ltd. | 1992-12-04 |
| K923774 | DISPOSABLE ENDOILLUMINATOR | O.R. Specialties, Inc. | 1992-10-19 |
| K922095 | LX 150 LIGHT SOURCE | Welch Allyn, Inc. | 1992-07-17 |
| K914586 | GRIESHABER THREE FUNCTION MANIPULATOR | Grieshaber & Co. | 1992-01-03 |
| K914585 | GRIESHABER TWO FUNCTION MANIPULATOR | Grieshaber & Co. | 1992-01-03 |
| K914247 | ASPIRATING ENDO OCULAR PROBE | Surgical Technologies, Inc. | 1991-12-18 |
| K912885 | KAPS 90 DEGREE FIBEROPTIC ADAPTOR | Jedmed Instrument Co. | 1991-08-30 |
| K912767 | FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC | Microaire Advanced Surgical Products | 1991-08-13 |
| K912522 | OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER | Summit Technology, Inc. | 1991-07-25 |
| K905437 | RIVER MEDICAL MICRODRILL SYSTEM | River Medical, Inc. | 1991-05-30 |
| K904378 | F.T.I. MEDICAL LIGHT GUIDE | Fiberoptics Technology, Inc. | 1991-01-16 |
| K904470 | SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE | Summit Technology, Inc. | 1990-12-24 |
| K902784 | FIBER OPTIC LIGHT SOURCE | Trek Medical Products, Inc. | 1990-09-12 |
| K896384 | FIBEROPTIC LIGHT SOURCE, FOI-1A | Jedmed Instrument Co. | 1990-01-23 |
| K864387 | LUXTEC FIBEROPTIC CABLES | Luxtec Corp. | 1987-05-22 |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | Luxtec Corp. | 1987-01-14 |
| K864382 | FRAZIER SUCTION TUBE | Luxtec Corp. | 1987-01-14 |
| K854751 | ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE | Aspen Laboratories, Inc. | 1986-02-28 |
| K841731 | BRIMFIELD FIBEROPTIC LIGHT SCOURCE | Brimfield Scientific Instruments | 1984-07-16 |
| K831589 | VENT TUBE FORCEPS | Treace Medical, Inc. | 1983-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190776413347 | Millennium | Avalign Technologies, Inc. | 2025-10-09 |
| 14026704933065 | PILLING | TELEFLEX INCORPORATED | 2025-04-28 |
| 14026704933058 | PILLING | TELEFLEX INCORPORATED | 2025-03-19 |
| 14026704933041 | PILLING | TELEFLEX INCORPORATED | 2025-03-19 |
| 10840199516015 | Fiberoptic Light Port | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199516008 | Fiberoptic Light Port | KOROS U.S.A., INC. | 2024-12-31 |
| 10840199515995 | Fiberoptic Dual End Cable | KOROS U.S.A., INC. | 2024-12-31 |
| 10381780539902 | MicroFrance® | INTEGRA MICROFRANCE | 2024-06-05 |
| 10381780539940 | MicroFrance® | INTEGRA MICROFRANCE | 2024-06-05 |
| 10381780540342 | MicroFrance® | INTEGRA MICROFRANCE | 2024-06-05 |
| 10381780540281 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780540311 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780540250 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539896 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 14026704921208 | PILLING | TELEFLEX INCORPORATED | 2024-02-13 |
| 14026704921314 | PILLING | TELEFLEX INCORPORATED | 2024-02-13 |
| 10845854040423 | CONMED | Conmed Corporation | 2023-12-05 |
| 14026704916907 | PILLING | TELEFLEX INCORPORATED | 2023-11-03 |
| 14026704916877 | PILLING | TELEFLEX INCORPORATED | 2023-11-03 |
| M6339982060 | JEDMED | JEDMED INSTRUMENT COMPANY | 2023-02-03 |
| G043MLGA4X7ST0 | BEAR | Bear-Ent, LLC | 2022-05-19 |
| G043MLGS4X7ST0 | BEAR | Bear-Ent, LLC | 2022-05-19 |
| G043MLGS4X7AC0 | BEAR | Bear-Ent, LLC | 2022-05-19 |
| G043MLGO4X7ST0 | BEAR | Bear-Ent, LLC | 2022-05-19 |
| G043MLGO4X7AC0 | BEAR | Bear-Ent, LLC | 2022-05-19 |
| G043MLGA4X7AC0 | BEAR | Bear-Ent, LLC | 2022-05-19 |
| 10885403151385 | Snowden-Pencer | CAREFUSION 2200, INC | 2018-07-13 |
| 10885403151378 | Snowden-Pencer | CAREFUSION 2200, INC | 2018-07-13 |
| M678HLC0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |
| M678FOC0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |