Pentax Upper G.I. Fiberscope, #FG-34
FDA 510(k) K810007 · Pentax Precision Instrument Corp.
510(k) numberK810007
Submission
- Device name
- Pentax Upper G.I. Fiberscope, #FG-34
- Applicant
- Pentax Precision Instrument Corp.
Mchenry, IL, US - Received
- January 5, 1981
- Decision date
- January 15, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDB – Endoscope, Fiber Optic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032283 | Designs for Vision Fiberoptic LightGDB · Special | Designs For Vision, Inc. | 08/20/2003SE |
| K961536 | FlexscopeGDB · Traditional | Matrix Medica, Inc. | 09/18/1996SE |
| K935818 | EndoscopeGDB · Traditional | Cuda Products Co. | 07/13/1994SE |
| K882061 | Olympus GF-UM3/EU-M3GDB · Traditional | Olympus Corp. | 11/15/1988SE |
| K855151 | Fritch Ophthalmic EndoscopeGDB · Traditional | Regtec | 02/19/1986SE |
| K843900 | Focuscope Universal SystemGDB · Traditional | Medical Diagnostics, Ca. | 12/06/1984SE |
More from Medical Diagnostics, Ca.
| 510(k) | Device | Decision |
|---|---|---|
| K041397 | EG-3830UTITX · Traditional | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K031789 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 08/08/2003SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
Questions and answers
When was Pentax Upper G.I. Fiberscope, #FG-34 cleared by the FDA?
Pentax Upper G.I. Fiberscope, #FG-34 (K810007) received a 510(k) decision of Substantially Equivalent on January 15, 1981, 10 days after the submission was received.
What is the product code of K810007?
The FDA product code is GDB – Endoscope, Fiber Optic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.