Skip to content

SpyGlass Discover Balloon Dilation Catheter

by Boston Scientific 510(k)

Active United States

510(k) K212582

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212582 Date6 May 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GCA
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Boston Scientific

See all devices from Boston Scientific →