510(k) K131532

ELECTROMAGNETIC TRANSMITTING STYLET by Corpak Medsystems — Product Code KNT

K131532 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "ELECTROMAGNETIC TRANSMITTING STYLET". The FDA issued a decision of Substantially Equivalent on August 12, 2013. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2013
Date Received
May 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type