Cleared Traditional

SB Knife Jr2 (MD-47702 and MD-47702L)

K241855 · Sb-Kawasumi Laboratories, Inc. · Gastroenterology & Urology
Mar 2025
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K241855 is an FDA 510(k) clearance for the SB Knife Jr2 (MD-47702 and MD-47702L), a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Sb-Kawasumi Laboratories, Inc. (Kawasaki-Shi, JP). The FDA issued a Cleared decision on March 26, 2025, 272 days after receiving the submission on June 27, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K241855 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2024
Decision Date March 26, 2025
Days to Decision 272 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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