Weco Endoscopic System with Fiber Optic Light
FDA 510(k) K945876 · Wells Johnson Co.
510(k) numberK945876
Submission
- Device name
- Weco Endoscopic System with Fiber Optic Light
- Applicant
- Wells Johnson Co.
Tucson, AZ, US - Received
- December 1, 1994
- Decision date
- December 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4350
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Truphatek, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K991437 | Wells Johnson Infusion System, Model 20-6000-00FRN · Traditional | 08/30/1999SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | 01/28/1999SE |
| K971580 | Uas Ultrasonic Aspirator SystemLFL · Traditional | 12/09/1997SE |
| K945500 | Wells Johnson Fixation SystemJEY · Traditional | 09/21/1995SE |
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | 06/14/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | 03/02/1995SE |
| K945805 | Wells Johnson Weco Monopolar/Frazier Suction ProbeGEI · Traditional | 12/13/1994SE |
| K854068 | External Mechanical Fastener · Traditional | 11/22/1985SE |
| K843188 | Wells Johnson Co. Chaj-Chir-Suction TipJOL · Traditional | 09/20/1984SE |
| K832521 | Plastic Suction TipsGEA · Traditional | 10/20/1983SE |
Questions and answers
When was Weco Endoscopic System with Fiber Optic Light cleared by the FDA?
Weco Endoscopic System with Fiber Optic Light (K945876) received a 510(k) decision of Substantially Equivalent on December 4, 1995, 368 days after the submission was received.
What is the product code of K945876?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.