510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944186Substantially Equivalent

Sinuscope

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

K944186 is the FDA 510(k) clearance record for SINUSCOPE, a class II device, cleared for Stryker Endoscopy on under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)). FDA's definition for product code EOB 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 CORP., from to . As of , FDA records show no recalls naming K944186.

Clearance record

Decision date
Received
(73 days to decision)
Product code
EOB Nasopharyngoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Stryker Endoscopy 210 Baypointe Pkwy., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code EOB

Trailing 12 months
5 clearances under product code EOB in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EOB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20262
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260