510(k) K210741

KLS Martin Neuro Rongeurs by KLS-Martin L.P. — Product Code HAE

K210741 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Neuro Rongeurs". The FDA issued a decision of Substantially Equivalent on June 3, 2022. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2022
Date Received
March 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type