Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PillCam Patency System

K-Number: K180171 · 2018-03-08

ApplicantGiven Imaging , Ltd.
Decision Date2018-03-08
Product CodeNSI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PillCam Patency System is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K180171. The device is classified under product code NSI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PillCam Patency System?

PillCam Patency System is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K180171.

When did PillCam Patency System receive FDA 510(k) clearance?

PillCam Patency System received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180171.

Who is the listed applicant for PillCam Patency System?

The FDA 510(k) record lists Given Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PillCam Patency System?

The FDA product code for PillCam Patency System is NSI.

Other records listing Given Imaging , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0K170839RAPID WebK151086ManoScan SystemK153466PillCam COLON 2 Capsule Endoscopy System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑