SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM— 510(k) K091515

Name: FDA 510(k) clearance K091515
Creator: U.S. Food and Drug Administration
Published: 2009-07-09

Substantially Equivalent

Novadaq Technologies, Inc.

FDA 510(k) clearance K091515 for SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM, Substantially Equivalent on 2009-07-09. Applicant: Novadaq Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Novadaq Technologies, Inc.
Product code: Code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-05-22
Decision date: 2009-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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K150956 — PINPOINT Endoscopic Fluorescence Imaging System2016-05-23
K123013 — ENDOSCOPIC INTRODUCER2013-03-22
K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM2011-02-04

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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 →

Recalls naming K091515

K-number listed on FDA's recall record

Z-1032-2016 — PINPOINT Endoscopic Fluorescence Imaging SystemClass II·Terminated·Novadaq Technologies Inc.·20160129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091515.

Data sourced from openFDA. This site is unofficial and independent of the FDA.