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FDA 510(k)

MODIFICATION TO INREACH SYSTEM

K-Number: K081379 · 2008-06-11

ApplicantSuperdimension, Ltd.
Decision Date2008-06-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO INREACH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Ltd.. It received FDA 510(k) clearance on 2008-06-11 under 510(k) number K081379. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO INREACH SYSTEM?

MODIFICATION TO INREACH SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-11. The listed applicant is Superdimension, Ltd.. The 510(k) number is K081379.

When did MODIFICATION TO INREACH SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO INREACH SYSTEM received FDA 510(k) clearance on 2008-06-11, under 510(k) number K081379.

Who is the listed applicant for MODIFICATION TO INREACH SYSTEM?

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

What is the FDA product code for MODIFICATION TO INREACH SYSTEM?

The FDA product code for MODIFICATION TO INREACH SYSTEM is JAK.

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Other records listing Superdimension, 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.

K102604I-LOGIC INREACH SYSTEMK092365INREACH SYSTEM, MODEL AAS00161-02K082386INREACH PLANNING LAPTOPK080271INREACH SYSTEMK071473MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2K062315SUPERDIMENSION/BRONCHUS PREMIUM 2

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Related Devices (Code: JAK)

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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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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