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SB Knife Jr2

SB-KAWASUMI LABORATORIES, INC. · Model MD-47702 · UDI-DI 04545499074423

KNS Prescription

510(k) clearances

17,379

Adverse events (81 deaths)

121

Recalls

118

Facilities

Description

The SB Knife Jr2 is a single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator and 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. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knife Jr2 is designed to connect with Olympus and ERBE connectors and use the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators. The device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-2-18 by ISO 17025 accredited laboratory.

Recalls

Date	Firm	Reason
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.