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SPY Portable Handheld Imaging (SPY-PHI) System

by Novadaq Technologies Ulc. (Now A Part of Stryker) 510(k)

Active United States

510(k) K190729

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESD Substantially Equivalent — Deferred · Special NumberK190729 Date19 Apr 2019ClearedStatusActive

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  • Withdrawn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
OWN
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESD Substantially Equivalent — Deferred

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