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FDA 510(k)

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE

K-Number: K071153 · 2007-06-11

ApplicantGiven Imaging , Ltd.
Decision Date2007-06-11
Product CodeNSI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE 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 2007-06-11 under 510(k) number K071153. 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 DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE?

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE is a medical device that received FDA 510(k) clearance on 2007-06-11. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K071153.

When did GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE receive FDA 510(k) clearance?

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE received FDA 510(k) clearance on 2007-06-11, under 510(k) number K071153.

Who is the listed applicant for GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE?

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 DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE?

The FDA product code for GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE is NSI.

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Other records listing Given Imaging , Ltd. as applicant

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K180171PillCam Patency SystemK170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0K170839RAPID WebK151086ManoScan SystemK153466PillCam COLON 2 Capsule Endoscopy SystemK123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM

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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.K090557GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEMGiven 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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