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
- Product 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
view allMore 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.