Frazier Suction Tube
FDA 510(k) K864382 · Luxtec Corp.
510(k) numberK864382
Submission
- Device name
- Frazier Suction Tube
- Applicant
- Luxtec Corp.
Sturbridge, MA, US - Received
- November 5, 1986
- Decision date
- January 14, 1987
- 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 |
|---|---|---|
| K973193 | LuxscopeHQF · Traditional | 11/21/1997SE |
| K970642 | TenoscopeHRX · Traditional | 05/21/1997SE |
| K970562 | TenosnareHRX · Traditional | 05/14/1997SE |
| K950960 | Reddy IlluminatorFFS · Traditional | 09/08/1995SE |
| K895248 | IMS5000 Illuminated LoupesFSP · Traditional | 09/15/1989SE |
| K890716 | Luxtec Aco Series 4000 Light SourceFCW · Traditional | 04/26/1989SE |
| K864387 | Luxtec Fiberoptic CablesEQH · Traditional | 05/22/1987SE |
| K864383 | Luxtec, Killian and Vienna Nasal SpeculumsEQH · Traditional | 01/14/1987SE |
| K864385 | Luxtec Light SourcesFCW · Traditional | 01/13/1987SE |
| K864865 | Speculum, Vaginal, Metal FiberopticHDG · Traditional | 01/09/1987SE |
Questions and answers
When was Frazier Suction Tube cleared by the FDA?
Frazier Suction Tube (K864382) received a 510(k) decision of Substantially Equivalent on January 14, 1987, 70 days after the submission was received.
What is the product code of K864382?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.