PillCam Patency System— 510(k) K180171

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K180171 for PillCam Patency System, Substantially Equivalent on 2018-03-08. Applicant: Given Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NSI
Device class: Class 2
Regulation: 21 CFR 876.1300
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-22
Decision date: 2018-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code NSI

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More clearances from Given Imaging , Ltd.

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K140284 — GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM2014-12-17

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