# K092309: Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 30, 2009 after 92 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 7 cite it directly.
0 of 16 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 its predicate without a number.
- (no number) KD-IL-1: named in the summary without a submission number

## Most influential descendants
- K171158: Single Use Electrosurgical knife (2017), 7 descendants of its own
- K151474: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (2016), 3 descendants of its own
- K161186: Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) (2016), 2 descendants of its own
- 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

## Recalls of this device
- Feb 17, 2024 · Class II · Z-1222-2026: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- Jan 4, 2021 · Class II · Z-0980-2021: 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-0977-2021: 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-0976-2021: 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-0974-2021: 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-0975-2021: 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-0978-2021: 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-0979-2021: 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-0981-2021: 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
Singqle Use Electrosurgical Knife KD-610OL/KD-61 IL/KD-620LR/KD-63OL/KD-640L This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

Source page: https://510kreport.com/device/K092309
Methodology: https://510kreport.com/methodology