EQH · Source, Carrier, Fiberoptic Light
Ear, Nose, Throat · 21 CFR 874.4350 · Class 1
Overview
| Product Code | EQH |
|---|---|
| Device Name | Source, Carrier, Fiberoptic Light |
| Regulation | 21 CFR 874.4350 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Wells Johnson Co. | Dec 4, 1995 | SESE |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | Jedmed Instrument Co. | Nov 13, 1995 | SESE |
| K951829 | COLD LIGHT SOURCE LOS 150 | Laser-Optik-Systeme GmbH & Co. KG | Jul 10, 1995 | SESE |
| K932771 | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | Xomed-Treace, Inc. | Aug 24, 1994 | SESE |
| K941661 | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT | Gm Engineering, Inc. | Aug 23, 1994 | SESE |
| K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT | Gm Engineering, Inc. | Jul 20, 1994 | SESE |
| K934911 | SAPHIRE PLUS SURGICAL MIRROR | San Diego Swiss Machining, Inc. | Jun 21, 1994 | SESE |
| K932131 | MID LABS TWIN ILLUMINATOR | Medical Instrument Development Laboratories, Inc. | Apr 1, 1994 | SESE |
| K930123 | ASPIRATING ENDO OCULAR PROBE | Surgical Technologies, Inc. | Feb 16, 1994 | SESE |
| K933145 | FIBEROPTIC LIGHTSOURCES AND CARRIERS | Electro Fiberoptics Corp. | Sep 7, 1993 | SESE |
| K923227 | THROAT-A-SCOPE | Truphatek, Ltd. | Dec 4, 1992 | SESE |
| K923774 | DISPOSABLE ENDOILLUMINATOR | O.R. Specialties, Inc. | Oct 19, 1992 | SESE |
| K922095 | LX 150 LIGHT SOURCE | Welch Allyn, Inc. | Jul 17, 1992 | SESE |
| K914586 | GRIESHABER THREE FUNCTION MANIPULATOR | Grieshaber & Co. | Jan 3, 1992 | SESE |
| K914585 | GRIESHABER TWO FUNCTION MANIPULATOR | Grieshaber & Co. | Jan 3, 1992 | SESE |
| K914247 | ASPIRATING ENDO OCULAR PROBE | Surgical Technologies, Inc. | Dec 18, 1991 | SESE |
| K912885 | KAPS 90 DEGREE FIBEROPTIC ADAPTOR | Jedmed Instrument Co. | Aug 30, 1991 | SESE |
| K912767 | FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC | Microaire Advanced Surgical Products | Aug 13, 1991 | SESE |
| K912522 | OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER | Summit Technology, Inc. | Jul 25, 1991 | SESE |
| K905437 | RIVER MEDICAL MICRODRILL SYSTEM | River Medical, Inc. | May 30, 1991 | SESE |
Top Applicants
- Aspen Laboratories, Inc. — 10 clearances
- Treace Medical, Inc. — 4 clearances
- Kelleher Corp. — 4 clearances
- Luxtec Corp. — 3 clearances
- Jedmed Instrument Co. — 3 clearances
