← Back to catalogue

SB Knife /Jr type - Long

FDA UDI

Class II (US FDA UDI)

by Sb-Kawasumi Laboratories, Inc.

Identity

Trade Name
SB Knife /Jr type - Long FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
The SB Knife 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 including Zenker’s diverticulum 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 is designed to connect with Olympus and ERBE connectors and uses 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 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan. FDA UDI
Model / Reference
MD-47703L FDA UDI
Description
The SB Knife 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 including Zenker’s diverticulum 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 is designed to connect with Olympus and ERBE connectors and uses 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 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan. FDA UDI

Identifiers

Primary DI / UDI-DI
04545499064677 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.6 Millimeter FDA UDI
Length — 2.3 Meter FDA UDI

Category: Endoscopic electrosurgical electrode, monopolar, single-use

SB Knife /Jr type - Long by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sb-Kawasumi Laboratories, Inc.

Sources (1)

  • FDA UDI 0e54a692-f6fb-4e2a-b9d1-509b06894c43 34 fields · synced May 30, 2026