510(k) K241855

SB Knife Jr2 (MD-47702 and MD-47702L) by Sb-Kawasumi Laboratories, Inc. — Product Code KNS

K241855 is an FDA 510(k) premarket notification submitted by Sb-Kawasumi Laboratories, Inc. for the device "SB Knife Jr2 (MD-47702 and MD-47702L)". The FDA issued a decision of Substantially Equivalent on March 26, 2025. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Sb-Kawasumi Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2025
Date Received
June 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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