OCSClass II

Endoscopic Video Imaging System/component, Gastroenterology-urology

Gastroenterology, Urology · 21 CFR 876.1500

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

MDR events5All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances1All time

Recent MDR events

5 adverse event reports on file

STRYKER SMART ROOM EQUIPMENT MEDIA ROUTERFeb 10, 2026
MalfunctionStryker Communications, Inc.MW5183604
PENTAXAug 11, 2021
MalfunctionHoya Corporation Pentax Tokyo Office9610877-2021-10347
PENTAXAug 11, 2021
MalfunctionHoya Corporation Pentax Tokyo Office9610877-2021-10346
SWITCHPOINT INFINITY 3Jan 2, 2018
MalfunctionStryker Corp.MW5074376
SWITCHPOINT INFINITYOct 3, 2017
MalfunctionStryker Communications Inc.6910415

Event type breakdown

Malfunction5

Most-reported manufacturers

Hoya Corporation Pentax Tokyo Office2 Stryker Communications Inc.1 Stryker Communications, Inc.1 Stryker Corp.1

Recalls

1 recall events for this product code

Olympus Corporation of the Americas
TerminatedUnknown
Uretero-reno videoscope URF-V2
Potential breakage of the endoscope s insertion tube bending section during surgical procedures
Z-2518-2018 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Stryker CommunicationsMay 6, 2010
K100852 · STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000