# K152771: SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

- Pathway: 510(k) (Traditional)
- Applicant: Sumitomo Bakelite Co., Ltd.
- Decided: Jun 17, 2016 after 266 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092309 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092309: Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L, Olympus Medical Systems Corporation (2009) Summary page 4.

## Recalls of this device
- Sep 9, 2016 · Class II · Z-0388-2017: Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
- Sep 9, 2016 · Class II · Z-0389-2017: Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type

## 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 within the digestive tract using high-frequency current.

Source page: https://510kreport.com/device/K152771
Methodology: https://510kreport.com/methodology