510(k) K222542

MCB UNIT Model: V10GMCBUS by Lamidey Noury Medical — Product Code KNS

K222542 is an FDA 510(k) premarket notification submitted by Lamidey Noury Medical for the device "MCB UNIT Model: V10GMCBUS". The FDA issued a decision of Substantially Equivalent on September 21, 2022. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Lamidey Noury Medical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2022
Date Received
August 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type