510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250040Unknown

SportSuite Vision Software

Stryker Corp., San Jose CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250040 is the FDA 510(k) clearance record for SportSuite Vision Software, a class II device, cleared for Stryker Endoscopy on under FDA product code SIT (Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System). FDA's definition for product code SIT reads: "This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization...". FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming DEN250040.

Clearance record

Decision date
Received
(318 days to decision)
Product code
SIT Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
Regulation
21 CFR 888.1150
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Endoscopy 5900 Optical Ct., San Jose CA
Third party review
No

Clearances, product code SIT

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