FGSClass II

Carrier, Sponge, Endoscopic

Gastroenterology, Urology · 21 CFR 876.1500

MDR events2All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances4All time

Recent MDR events

2 adverse event reports on file

INFRAVISION IR ILLUMINATORSep 26, 2014
MalfunctionStryker Endoscopy-san Jose0002936485-2014-00758
VHA + PLUS LAPAROTOMY SPONGESJan 9, 1994
InjuryMedical Action7500

Event type breakdown

Injury1

Malfunction1

Most-reported manufacturers

Medical Action1 Stryker Endoscopy-san Jose1

Recalls

1 recall events for this product code

Stryker Endoscopy
TerminatedJan 18, 2011
InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system.
Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.
Z-0906-2011 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

4 clearances for this product code