Source, Carrier, Fiberoptic Light
FDA product code EQH · Class I (low risk) · 21 CFR 874.4350 · Ear, Nose, Throat
49510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Aspen Laboratories, Inc. 10
- Kelleher Corp. 4
- Treace Medical, Inc. 4
- Luxtec Corp. 3
- Jedmed Instrument Co. 3
- Gm Engineering, Inc. 2
- Grieshaber & Co. 2
- Surgical Technologies, Inc. 2
- Summit Technology, Inc. 2
- Trek Medical Products, Inc. 1
- Brimfield Scientific Instruments 1
- Fiberoptics Technology, Inc. 1
- River Medical, Inc. 1
- Microaire Advanced Surgical Products 1
- Applied Fiberoptics, Inc. 1
- Dale Medical Products, Inc. 1
- Welch Allyn, Inc. 1
- O.R. Specialties, Inc. 1
- Truphatek, Ltd. 1
- Wells Johnson Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | Wells Johnson Co. | 12/04/1995SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | Jedmed Instrument Co. | 11/13/1995SE |
| K951829 | Cold Light Source Los 150EQH · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 07/10/1995SE |
| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | Xomed-Treace, Inc. | 08/24/1994SE |
| K941661 | GM Opti*Cam Camer with Dental Fiber Optic LightEQH · Traditional | Gm Engineering, Inc. | 08/23/1994SE |
| K941662 | GM Opti*Cam Camera with ENT Fiber Optic LightEQH · Traditional | Gm Engineering, Inc. | 07/20/1994SE |
| K934911 | Saphire Plus Surgical MirrorEQH · Traditional | San Diego Swiss Machining, Inc. | 06/21/1994SE |
| K932131 | Mid Labs Twin IlluminatorEQH · Traditional | Medical Instrument Development Laboratories, Inc. | 04/01/1994SE |
| K930123 | Aspirating Endo Ocular ProbeEQH · Traditional | Surgical Technologies, Inc. | 02/16/1994SE |
| K933145 | Fiberoptic Lightsources and CarriersEQH · Traditional | Electro Fiberoptics Corp. | 09/07/1993SE |
| K923227 | Throat-A-ScopeEQH · Traditional | Truphatek, Ltd. | 12/04/1992SE |
| K923774 | Disposable EndoilluminatorEQH · Traditional | O.R. Specialties, Inc. | 10/19/1992SE |
| K922095 | LX 150 Light SourceEQH · Traditional | Welch Allyn, Inc. | 07/17/1992SE |
| K914586 | Grieshaber Three Function ManipulatorEQH · Traditional | Grieshaber & Co. | 01/03/1992SE |
| K914585 | Grieshaber Two Function ManipulatorEQH · Traditional | Grieshaber & Co. | 01/03/1992SE |
| K914247 | Aspirating Endo Ocular ProbeEQH · Traditional | Surgical Technologies, Inc. | 12/18/1991SE |
| K912885 | Kaps 90 Degree Fiberoptic AdaptorEQH · Traditional | Jedmed Instrument Co. | 08/30/1991SE |
| K912767 | Fiber Optic Univeral Cables, Scope Adap., Lt.SourcEQH · Traditional | Microaire Advanced Surgical Products | 08/13/1991SE |
| K912522 | Omniview(Tm) Ophthalmic Fiberendo W/NeedleholderEQH · Traditional | Summit Technology, Inc. | 07/25/1991SE |
| K905437 | River Medical Microdrill SystemEQH · Traditional | River Medical, Inc. | 05/30/1991SE |
| K904378 | F.T.I. Medical Light GuideEQH · Traditional | Fiberoptics Technology, Inc. | 01/16/1991SE |
| K904470 | Summit Tech 19/20 Gauge Ophthalmic FiberendoscopeEQH · Traditional | Summit Technology, Inc. | 12/24/1990SE |
| K902784 | Fiber Optic Light SourceEQH · Traditional | Trek Medical Products, Inc. | 09/12/1990SE |
| K896384 | Fiberoptic Light Source, FOI-1AEQH · Traditional | Jedmed Instrument Co. | 01/23/1990SE |
| K864387 | Luxtec Fiberoptic CablesEQH · Traditional | Luxtec Corp. | 05/22/1987SE |
| K864383 | Luxtec, Killian and Vienna Nasal SpeculumsEQH · Traditional | Luxtec Corp. | 01/14/1987SE |
| K864382 | Frazier Suction TubeEQH · Traditional | Luxtec Corp. | 01/14/1987SE |
| K854751 | Zimmer Video Products Automatic Light SourceEQH · Traditional | Aspen Laboratories, Inc. | 02/28/1986SE |
| K841731 | Brimfield Fiberoptic Light ScourceEQH · Traditional | Brimfield Scientific Instruments | 07/16/1984SE |
| K831589 | Vent Tube ForcepsEQH · Traditional | Treace Medical, Inc. | 06/16/1983SE |
| K831590 | T-Tube InserterEQH · Traditional | Treace Medical, Inc. | 06/15/1983SE |
| K823437 | Mcgee 26GA. Suction TubeEQH · Traditional | Treace Medical, Inc. | 12/09/1982SE |
| K823436 | Microsurgical GaugeEQH · Traditional | Treace Medical, Inc. | 12/09/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | Kelleher Corp. | 10/22/1982SE |
| K822282 | Fiberoptic Light CarriersEQH · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822192 | Fiberoptic Light CarriersEQH · Traditional | Kelleher Corp. | 08/20/1982SE |
| K822175 | Adaptor for Fiberoptic Light SourceEQH · Traditional | Kelleher Corp. | 08/20/1982SE |
| K820621 | Nasal InstrumentsEQH · Traditional | Applied Fiberoptics, Inc. | 03/19/1982SE |
| K812429 | Dale Combo Tracheostomy Tube HolderEQH · Traditional | Dale Medical Products, Inc. | 09/23/1981SE |
| K802775 | Fiber Optic Adapter #60-0896EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802774 | Fiber Optic Adapter #60-0892EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802773 | Fiber Optic Light Guide #60-0767EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802772 | Fiber Optic Adapter #60-0894EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802771 | Fiber Optic Adapter #60-895EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802768 | Fiber Optic Adapter #60-0897EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802767 | Fiber Optic Light Guide CAT#60-0768EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K802766 | Fiber Optic Adapter CAT#60-0898EQH · Traditional | Aspen Laboratories, Inc. | 12/16/1980SE |
| K801176 | Fiber Optic Light SourceEQH · Traditional | Aspen Laboratories, Inc. | 05/28/1980SE |
| K760653 | Adapter/Standard Fiber Optics LightEQH · Traditional | Pilling Co. | 12/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0698-2007 | Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210Light Degradation in transmission-A film may deposit on the front face and limit transmission of light | Boston Scientific Corporation | 02/07/2007Terminated |