DeviceClearance

Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210) +6 more— 510(k) K250517

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K250517 for Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210) +6 more, Substantially Equivalent on 2025-03-21. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Device name as filed
Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
Applicant
Boston Scientific Corporation
Product code
Code FED
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Marlborough, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FED

product code FED
Death
10
Total
10

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.