SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long— 510(k) K152771

Clearance details

Applicant

Sumitomo Bakelite Co., Ltd.

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2015-09-25

Decision date

2016-06-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tokyo, JP

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• K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17

• K182520 — Flexible Overtube2019-05-15
• K190621 — SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long2019-04-23
• K173004 — SB Soft Hood - Straight type, SB Soft Hood - Undercut type2018-05-08

Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0388-2017 — SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.Class II·Terminated·Akita Sumitomo Bakelite Co., Ltd.·20160909
• Z-0389-2017 — SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.Class II·Terminated·Akita Sumitomo Bakelite Co., Ltd.·20160909

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152771.