510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K231854Substantially Equivalent

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

Stryker Corp., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231854 is the FDA 510(k) clearance record for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM, a class II device, cleared for Stryker on under FDA product code OWN (Confocal Optical Imaging). FDA's definition for product code OWN reads: "Collection of light signals for visualization of cellular microstructures". FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show no recalls naming K231854.

Clearance record

Decision date
Received
(89 days to decision)
Product code
OWN Confocal Optical Imaging
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Stryker 5900 Optical Ct., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWN

Trailing 12 months
8 clearances under product code OWN in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWN, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20264
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260