PINPOINT Endoscopic Fluorescence Imaging System— 510(k) K150956

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

2015-04-09

Decision date

2016-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burnaby, CA

• K262397 — CuratOR EX27422026-09-11
• K260884 — UNIDRIVE Select System2026-09-01
• K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor2026-08-26
• K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)2026-08-13
• K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)2026-07-24

• K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System2017-01-11
• K161792 — PINPOINT Endoscopic Fluorescence Imaging System2016-09-20
• K123013 — ENDOSCOPIC INTRODUCER2013-03-22
• K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM2011-02-04
• K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM2009-07-09

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 →

• Z-1428-2021 — Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.Class II·Terminated·Stryker Corporation·20210226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150956.