Grieshaber Three Function Manipulator
FDA 510(k) K914586 · Grieshaber & Co.
510(k) numberK914586
Submission
- Device name
- Grieshaber Three Function Manipulator
- Applicant
- Grieshaber & Co.
Langhorne, PA, US - Received
- October 16, 1991
- Decision date
- January 3, 1992
- 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 |
|---|---|---|---|
| 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 |
More from Electro Fiberoptics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K950056 | The Grieshaber Axial CutterHKP · Traditional | 05/05/1995SE |
| K930842 | The Grieshaber Syst/Ai Tubing Set and CartridgeHQE · Traditional | 05/03/1994SE |
| K914588 | Grieshaber Snare Instrument and Snare CartridgeGAW · Traditional | 06/11/1992SE |
| K914587 | Grieshaber Air/Fluid Tubing SetKYG · Traditional | 01/23/1992SE |
| K914585 | Grieshaber Two Function ManipulatorEQH · Traditional | 01/03/1992SE |
| K897119 | Grieshaber Retinal Tack and Sutherland Tack ForcepHQW · Traditional | 04/12/1990SE |
| K900714 | Zzipp Instant Bovie CleanerGEI · Traditional | 03/27/1990SE |
| K890782 | Grieshaber Soft Tip Needle (20 & 19 Gauges)HMX · Traditional | 06/23/1989SE |
| K890783 | Grieshaber Viscoelastic Injection SystemFRN · Traditional | 05/16/1989SE |
| K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 GaugeHQE · Traditional | 11/16/1988SE |
Questions and answers
When was Grieshaber Three Function Manipulator cleared by the FDA?
Grieshaber Three Function Manipulator (K914586) received a 510(k) decision of Substantially Equivalent on January 3, 1992, 79 days after the submission was received.
What is the product code of K914586?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.