Pentax Medical Video Duodenoscope ED32-i10
FDA 510(k) K202365 · Pentax of America, Inc.
510(k) numberK202365
Submission
- Device name
- Pentax Medical Video Duodenoscope ED32-i10
- Applicant
- Pentax of America, Inc.
Montvale, NJ, US - Received
- August 19, 2020
- Decision date
- April 1, 2021
- 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
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|---|---|---|---|
| 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 |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 12/08/2020SE |
| K203028 | FUJIFILM Distal End CapFDT · Special | Fujifilm Corporation | 10/30/2020SE |
More from Fujifilm Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | 12/16/2025SE |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c)PEA · Traditional | 06/03/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | 01/03/2025SE |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…FDS · Traditional | 12/06/2024SE |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | 08/01/2024SE |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH · Traditional | 07/24/2024SE |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…EOQ · Traditional | 01/18/2024SE |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…EOQ · Traditional | 01/12/2024SE |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14ODC · Traditional | 12/01/2023SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | 07/28/2023SE |
Questions and answers
When was Pentax Medical Video Duodenoscope ED32-i10 cleared by the FDA?
Pentax Medical Video Duodenoscope ED32-i10 (K202365) received a 510(k) decision of Substantially Equivalent on April 1, 2021, 225 days after the submission was received.
What is the product code of K202365?
The FDA product code is FDT – Duodenoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.