510(k) K982542

STRYKER URETERAL ILLUMINATOR SYSTEM III by Stryker Endoscopy — Product Code FCS

K982542 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER URETERAL ILLUMINATOR SYSTEM III". The FDA issued a decision of Substantially Equivalent on September 22, 1998. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Stryker Endoscopy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
July 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class
Class II
Regulation Number
876.4020
Review Panel
GU
Submission Type