# K190621: SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

- Pathway: 510(k) (Traditional)
- Applicant: Sumitomo Bakelite Co., Ltd.
- Decided: Apr 23, 2019 after 43 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K241855: SB Knife Jr2 (MD-47702 and MD-47702L) (2025), 0 descendants of its own

## Indications for use
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 including Zenker’s diverticulum within the digestive tract using high-frequency current.

Source page: https://510kreport.com/device/K190621
Methodology: https://510kreport.com/methodology