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The Tracker / August 2026 / K253692

510(k) cleared

AVVIGO+ Multi-Modality Guidance System

Boston Scientific · Aug 21, 2026 · K253692

FDA cleared the AVVIGO+ Multi-Modality Guidance System from Boston Scientific on Aug 21, 2026 under K253692, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 21, 2025. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Boston Scientific has 8 other decisions in the tracker over the last 12 months: K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261915 (Navigator Flex Ureteral Access Sheath Set), K261488 (OBSIDIO Conformable Embolic).

Questions & Answers

What did FDA clear under K253692?

K253692 is the FDA 510(k) for AVVIGO+ Multi-Modality Guidance System, submitted by Boston Scientific. FDA's decision date was Aug 21, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the AVVIGO+ Multi-Modality Guidance System?

Boston Scientific, based in Maple Grove, MN, is the applicant of record for K253692.

How long did the K253692 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Aug 21, 2026, 273 days later.

← All decisions in August 2026