River Medical Microdrill System
FDA 510(k) K905437 · River Medical, Inc.
510(k) numberK905437
Submission
- Device name
- River Medical Microdrill System
- Applicant
- River Medical, Inc.
Memphis, TN, US - Received
- December 4, 1990
- Decision date
- May 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4350
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
| 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 |
|---|---|---|
| K023174 | Disposable Temporary Pacing WireLDF · Traditional | 06/11/2003SE |
| K944352 | Smartdose III Infusion ContainerFRN · Traditional | 11/15/1995ST |
| K944351 | Smartdose IV Prefilled Infusion ContainerFRN · Traditional | 11/15/1995ST |
| K945298 | Smartflow I Administration SetFPA · Traditional | 06/14/1995SE |
| K943692 | Smart Dose(Tm)FRN · Traditional | 04/28/1995ST |
| K932895 | River PumpFRN · Traditional | 03/31/1994SE |
| K933335 | River Vial AdapterFMF · Traditional | 03/01/1994SE |
| K915120 | Tef/Platinum PistonETB · Traditional | 12/27/1991SE |
| K915121 | Tef/Wire PistonETB · Traditional | 12/23/1991SE |
| K913287 | H/A Partial - Regular & H/A Partial - OffsetETB · Traditional | 12/18/1991SE |
Questions and answers
When was River Medical Microdrill System cleared by the FDA?
River Medical Microdrill System (K905437) received a 510(k) decision of Substantially Equivalent on May 30, 1991, 177 days after the submission was received.
What is the product code of K905437?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.