Pathfinder Endoscope Overtube with Balloon Device
FDA 510(k) K230801 · Neptune Medical, Inc.
510(k) numberK230801
Submission
- Device name
- Pathfinder Endoscope Overtube with Balloon Device
- Applicant
- Neptune Medical, Inc.
Burlingame, CA, US - Received
- March 23, 2023
- Decision date
- July 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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|---|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/11/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | Boston Scientific Corporation | 08/04/2026SE |
| K260965 | CVAC Aspiration SystemFED · Special | Calyxo, Inc. | 04/13/2026SE |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…FED · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 04/06/2026SE |
| K252572 | Prodeon Urethral Sheath SystemFED · Traditional | Prodeon Medical, Inc. | 10/07/2025SE |
| K250128 | Single Use Suction-Evacuation Ureteral Access SheathFED · Traditional | Anhui Happiness Workshop Medical Instruments… | 09/19/2025SE |
| K250132 | Ureteral Access SheathFED · Traditional | Zhejiang YiGao Medical Technology Co., Ltd. | 09/05/2025SE |
| K250695 | Single-use Ureteral Access SheathFED · Traditional | Shenzhen HugeMed Medical Technical Development… | 07/08/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | Hunan Vathin Medical Instrument Co., Ltd. | 07/03/2025SE |
| K250585 | LumenaTM Ureteral Access SheathFED · Traditional | Cathegenix (Xiamen) Co., Ltd. | 06/27/2025SE |
More from Cathegenix (Xiamen) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | 09/03/2026SE |
| K240853 | Pathfinder® CR SystemFED · Traditional | 06/27/2024SESK |
| K211301 | Pathfinder Endoscope OvertubeFED · Special | 05/28/2021SE |
| K210915 | Pathfinder Endoscope CapFDS · Traditional | 05/25/2021SE |
| K191415 | Pathfinder Endoscope OvertubeFED · Traditional | 08/30/2019SE |
Questions and answers
When was Pathfinder Endoscope Overtube with Balloon Device cleared by the FDA?
Pathfinder Endoscope Overtube with Balloon Device (K230801) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 127 days after the submission was received.
What is the product code of K230801?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.