# K182408: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: May 15, 2019 after 253 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K952726 (1995). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171158: Single Use Electrosurgical knife, Olympus Medical Systems Corp. (2017) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Mar 1, 2024 · Class II · Z-1547-2024: Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with
- Mar 1, 2024 · Class II · Z-1548-2024: Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with
- Feb 17, 2024 · Class II · Z-1223-2026: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

## Indications for use
KD-625 These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. KD-645 This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. This instrument is 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/K182408
Methodology: https://510kreport.com/methodology