Battery Powered, Disposable Endoscope Light Source
FDA 510(k) K932771 · Xomed-Treace, Inc.
510(k) numberK932771
Submission
- Device name
- Battery Powered, Disposable Endoscope Light Source
- Applicant
- Xomed-Treace, Inc.
Jacksonville, FL, US - Received
- June 8, 1993
- Decision date
- August 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
|---|---|---|
| K940028 | Endoscope SheathEOB · Traditional | 03/24/1995SE |
| K941407 | Tympanostomy (Ventilation) TubeETD · Traditional | 03/14/1995SE |
| K945659 | Blackstar(Tm) Star SystemERL · Traditional | 01/09/1995SE |
| K933672 | Xomed-Treace ScopesheathEOB · Traditional | 07/18/1994SE |
| K934426 | Nerve Integrity MONITOR-2 (NIM-2 XL)ETN · Traditional | 05/13/1994SE |
| K933105 | Xomed-Treace Rigid Rod Lens EndoscopeEOB · Traditional | 01/05/1994SE |
| K925640 | Xomed-Treace Emg Endotracheal TubeenETN · Traditional | 08/17/1993SE |
| K922880 | Xomed Treace Jet Ventilation TubeBTR · Traditional | 04/15/1993SE |
| K923830 | Xomed-Treace AlphascopeERA · Traditional | 11/09/1992SE |
| K912753 | Xomed-Treace Positrol Footpedal Suction ControlGCX · Traditional | 09/23/1991SE |
Questions and answers
When was Battery Powered, Disposable Endoscope Light Source cleared by the FDA?
Battery Powered, Disposable Endoscope Light Source (K932771) received a 510(k) decision of Substantially Equivalent on August 24, 1994, 442 days after the submission was received.
What is the product code of K932771?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.