SPY Phi Open Field Handheld Fluorescence Imaging System— 510(k) K162885

Clearance details

Applicant

Novadaq Technologies, Inc.

Product code

Code OWN

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2016-10-17

Decision date

2017-01-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burnaby, CA

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• K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)2026-02-13
• K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040)2026-02-12

• K161792 — PINPOINT Endoscopic Fluorescence Imaging System2016-09-20
• K150956 — PINPOINT Endoscopic Fluorescence Imaging System2016-05-23
• K123013 — ENDOSCOPIC INTRODUCER2013-03-22
• K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM2011-02-04
• K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM2009-07-09

Malfunction

1,286

Total

1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1925-2020 — Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282Class II·Ongoing·Stryker Corporation·20200107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162885.