Skip to content

Spyglass Direct Visualization Probe and Ocular

by Boston Scientific 510(k)

Active United States

510(k) K052194

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052194 Date24 Aug 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0697-2007 FDA Unclassified (pre-2012) initiated 7 Feb 2007 on shared 510(k) K052194
    • Terminated Z-0696-2007 FDA Unclassified (pre-2012) initiated 7 Feb 2007 on shared 510(k) K052194

    SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
ODF
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Boston Scientific

See all devices from Boston Scientific →