Navigator Flex Ureteral Access Sheath Set
FDA 510(k) K261915 · Boston Scientific Corporation
510(k) numberK261915
Submission
- Device name
- Navigator Flex Ureteral Access Sheath Set
- Applicant
- Boston Scientific Corporation
Marlborough, MA, US - Received
- June 9, 2026
- Decision date
- August 4, 2026
- 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.
Other 510(k)s with product code FED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/11/2026SE |
| 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 |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B…FED · Traditional | MacroLux Medical Technology Co., Ltd. | 06/02/2025SE |
More from MacroLux Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
| K260428 | RIVOS EUS Access Device (M00553900)ODG · Traditional | 06/17/2026SE |
Questions and answers
When was Navigator Flex Ureteral Access Sheath Set cleared by the FDA?
Navigator Flex Ureteral Access Sheath Set (K261915) received a 510(k) decision of Substantially Equivalent on August 4, 2026, 56 days after the submission was received.
What is the product code of K261915?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.