PINPOINT Endoscopic Fluorescence Imaging System— 510(k) K182606
Substantially EquivalentNovadaq Technologies Ulc. (Now A Part of Stryker)
FDA 510(k) clearance K182606 for PINPOINT Endoscopic Fluorescence Imaging System, Substantially Equivalent on 2018-11-21. Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker). Device class: 2.
Clearance details
- Applicant
- Novadaq Technologies Ulc. (Now A Part of Stryker)
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnaby, CA
Recent devices under product code GCJ
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- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Novadaq Technologies Ulc. (Now A Part of Stryker)
view all- K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment Software
- K200737 — SPY Portable Handheld Imaging (SPY-PHI) System
- K192174 — SPY Portable Handheld Imaging (SPY-PHI) System
- K190729 — SPY Portable Handheld Imaging (SPY-PHI) System
- K182907 — SPY Elite Intraoperative Perfusion Assessment System
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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.