Single Use Electrosurgical knife— 510(k) K171158

Clearance details

Applicant

Olympus Medical Systems Corp.

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2017-04-20

Decision date

2017-11-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hachioji-Shi, JP

• K262460 — Rezum System2026-09-03
• K260962 — Sphincterotome2026-05-21
• K252388 — Vanquish Water Vapor Ablation Device2025-11-26
• K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
• K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17

• K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB2026-09-10
• K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more2026-07-01
• K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more2026-05-21
• K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)2026-04-23
• K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR2026-03-06

Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0982-2021 — KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.Class II·Terminated·Aomori Olympus Co., Ltd.·20210104
• Z-0983-2021 — KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.Class II·Terminated·Aomori Olympus Co., Ltd.·20210104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171158.