510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K211202Substantially Equivalent

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes

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

K211202 is the FDA 510(k) clearance record for 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes, a class II device, cleared for Stryker on under FDA product code GWG (Endoscope, Neurological). FDA's definition for product code GWG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show no recalls naming K211202.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Stryker 5900 Optical Ct., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWG

Trailing 12 months
2 clearances under product code GWG in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260