Pentax Flexible Driodenofiberscope
FDA 510(k) K812810 · Pentax Precision Instrument Corp.
510(k) numberK812810
Submission
- Device name
- Pentax Flexible Driodenofiberscope
- Applicant
- Pentax Precision Instrument Corp.
Mchenry, IL, US - Received
- October 6, 1981
- Decision date
- November 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAK – Panendoscope (Gastroduodenoscope)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K760822 | Model TX-8 PanendoscopeFAK · Traditional | American Cystocope Makers, Inc. | 10/21/1976SE |
More from American Cystocope Makers, Inc.
| 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 Flexible Driodenofiberscope cleared by the FDA?
Pentax Flexible Driodenofiberscope (K812810) received a 510(k) decision of Substantially Equivalent on November 17, 1981, 42 days after the submission was received.
What is the product code of K812810?
The FDA product code is FAK – Panendoscope (Gastroduodenoscope), a Class II (moderate risk) device regulated under 21 CFR 876.1500.