PENTAX MEDICAL ED-3490TK, Video Duodenoscope
FDA 510(k) K161222 · Pentax Medical
510(k) numberK161222
Submission
- Device name
- PENTAX MEDICAL ED-3490TK, Video Duodenoscope
- Applicant
- Pentax Medical
Montvale, NJ, US - Received
- April 29, 2016
- Decision date
- February 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDT – Duodenoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine the duodenum and to perform various procedures within the duodenum. 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 FDT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | Fujifilm Corporation | 03/09/2026SE |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315)FDT · Traditional | Olympus Medical Systems Corp. | 02/22/2026SE |
| K251867 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDT · Traditional | Olympus Medical Systems Corp. | 09/19/2025SE |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDT · Traditional | Olympus Medical Systems Corp. | 06/05/2025SE |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | Pentax of America, Inc. | 08/01/2024SE |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2FDT · Traditional | Ambu A/S | 04/16/2024SE |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 05/11/2022SE |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2FDT · Special | Pentax of America, Inc. | 04/09/2021SE |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10FDT · Traditional | Pentax of America, Inc. | 04/01/2021SE |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 12/08/2020SE |
More from Olympus Medical Systems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K192280 | PENTAX Medical ED-3490TK Video DuodenoscopeFDT · Traditional | 10/21/2019SE |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB · Traditional | 07/18/2018SE |
| K172156 | PENTAX Medical EPK-3000 Video Imaging SystemEOB · Traditional | 04/05/2018SE |
| K163614 | PENTAX Medical ED34-i10T, Video DuodenoscopeFDT · Traditional | 09/20/2017SE |
| K131946 | Entax Ultrasound Video Bronchoscope EB-1970UK + Hi Visin PreirusEOQ · Traditional | 04/25/2014SE |
| K131902 | Pentax Video Upper G.I. Scopes (Eg Family)FDS · Traditional | 04/10/2014SE |
| K131028 | Pentax Video Bronchoscopes (Eb Family)EOQ · Traditional | 04/10/2014SE |
| K131855 | Pentax Video Colonoscopes (Ec Family)FDF · Traditional | 04/09/2014SE |
| K122470 | Pentax EPK-I5010 Video ProcessorPEA · Traditional | 04/10/2013SE |
| K093037 | Pentex EC-3890LIFDF · Traditional | 12/28/2009SE |
Questions and answers
When was PENTAX MEDICAL ED-3490TK, Video Duodenoscope cleared by the FDA?
PENTAX MEDICAL ED-3490TK, Video Duodenoscope (K161222) received a 510(k) decision of Substantially Equivalent on February 7, 2018, 649 days after the submission was received.
What is the product code of K161222?
The FDA product code is FDT – Duodenoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.