PENTAX Medical Gas/Water Feeding Valve OE-B14
FDA 510(k) K232249 · Pentax of America, Inc.
510(k) numberK232249
Submission
- Device name
- PENTAX Medical Gas/Water Feeding Valve OE-B14
- Applicant
- Pentax of America, Inc.
Montvale, NJ, US - Received
- July 28, 2023
- Decision date
- December 1, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special | STERIS Corporation | 10/11/2024SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 10/01/2024SE |
More from Alton (Shanghai) Medical Instruments Co., Ltd.
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|---|---|---|
| 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 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | 07/28/2023SE |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemEOQ · Traditional | 12/21/2022SE |
Questions and answers
When was PENTAX Medical Gas/Water Feeding Valve OE-B14 cleared by the FDA?
PENTAX Medical Gas/Water Feeding Valve OE-B14 (K232249) received a 510(k) decision of Substantially Equivalent on December 1, 2023, 126 days after the submission was received.
What is the product code of K232249?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.