MONOFILAMENT POLYPECTOMY SNARE— 510(k) K140763

Name: FDA 510(k) clearance K140763
Creator: U.S. Food and Drug Administration
Published: 2014-04-24

Substantially Equivalent

United States Endoscopy

FDA 510(k) clearance K140763 for MONOFILAMENT POLYPECTOMY SNARE, Substantially Equivalent on 2014-04-24. Applicant: United States Endoscopy. Device class: 2.

Clearance details

Applicant: United States Endoscopy
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-27
Decision date: 2014-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FDI

view all

K251692 — Advanced Tissue Resection Device2026-02-21
K221713 — Polypectomy Snare2023-03-03
K220846 — CORE-SNARE2022-11-21
K220089 — Disposable Polyp Snare2022-09-22
K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare2022-06-27

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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 →

Recalls naming K140763

K-number listed on FDA's recall record

Z-0001-2016 — Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.Class II·Terminated·US Endoscopy Group Inc·20150714

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140763.

Data sourced from openFDA. This site is unofficial and independent of the FDA.