K241855 is an FDA 510(k) clearance for the SB Knife Jr2 (MD-47702 and MD-47702L). This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K241855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | KNS - Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |