510(k) K001698

MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 by Cogent Light Technologies, Inc. — Product Code FFS

K001698 is an FDA 510(k) premarket notification submitted by Cogent Light Technologies, Inc. for the device "MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159". The FDA issued a decision of Substantially Equivalent on July 17, 2000. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Cogent Light Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2000
Date Received
June 2, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type