DeviceClearance

1688 Camera Control Unit +4 more— 510(k) K182160

Substantially Equivalent

Stryker

FDA 510(k) clearance K182160 for 1688 Camera Control Unit +4 more, Substantially Equivalent on 2018-11-05. Applicant: Stryker. Device class: 2.

Clearance details

Device name as filed
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
Applicant
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
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

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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 →

Recalls naming K182160

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182160.

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