# K171158: Single Use Electrosurgical knife

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Nov 17, 2017 after 211 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: 8 generations back to K952726 (1995). 31 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 39 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 5.
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe, Erbe USA, Inc. (2015) Summary page 5.
- K083608: Erbe Hybrid Knife, Erbe USA, Inc. (2009) Summary page 5.

## Most influential descendants
- K193601: Single Use Electrosurgical Knife (2020), 1 descendant of its own
- K182408: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (2019), 1 descendant of its own
- K250351: Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (2025), 0 descendants of its own
- K212999: Multi-Functional Electrosurgical Knife (2022), 0 descendants of its own
- K211172: Single Use Electrosurgical Knife with Fluid Pump System (2021), 0 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0983-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0982-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

## Indications for use
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

Source page: https://510kreport.com/device/K171158
Methodology: https://510kreport.com/methodology