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FDA 510(k)

GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM

K-Number: K090557 · 2009-09-28

ApplicantGiven Imaging , Ltd.
Decision Date2009-09-28
Product CodeNSI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE 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 2009-09-28 under 510(k) number K090557. 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 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM?

GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-28. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K090557.

When did GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM receive FDA 510(k) clearance?

GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM received FDA 510(k) clearance on 2009-09-28, under 510(k) number K090557.

Who is the listed applicant for GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE 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 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM?

The FDA product code for GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM is NSI.

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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.

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Related Devices (Code: NSI)

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.

K180171PillCam Patency SystemGiven Imaging , Ltd.K071153GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULEGiven Imaging , Ltd.K060805MODIFICATION TO GIVEN DIAGNOSTIC SYSTEMGiven Imaging , Ltd.K052184GIVEN DIAGNOSTIC SYSTEMGiven Imaging , Ltd.K042960GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESOGiven Imaging , Ltd.K041149GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULEGiven Imaging , Ltd.

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.

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