SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)— 510(k) K242923

Name: FDA 510(k) clearance K242923
Creator: U.S. Food and Drug Administration
Published: 2024-12-20

Substantially Equivalent

Envision Endoscopy

FDA 510(k) clearance K242923 for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230), Substantially Equivalent on 2024-12-20. Applicant: Envision Endoscopy. Device class: 2.

Clearance details

Applicant: Envision Endoscopy
Product code: Code OCZ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-24
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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