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FDA 510(k)

SUPERDIMENSION/BRONCHUS

K-Number: K042438 · 2004-11-08

ApplicantSuperdimension, Ltd.
Decision Date2004-11-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPERDIMENSION/BRONCHUS is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Ltd.. It received FDA 510(k) clearance on 2004-11-08 under 510(k) number K042438. 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 SUPERDIMENSION/BRONCHUS?

SUPERDIMENSION/BRONCHUS is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Superdimension, Ltd.. The 510(k) number is K042438.

When did SUPERDIMENSION/BRONCHUS receive FDA 510(k) clearance?

SUPERDIMENSION/BRONCHUS received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042438.

Who is the listed applicant for SUPERDIMENSION/BRONCHUS?

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 SUPERDIMENSION/BRONCHUS?

The FDA product code for SUPERDIMENSION/BRONCHUS 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 LAPTOPK081379MODIFICATION TO INREACH SYSTEMK080271INREACH SYSTEMK071473MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2

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Related Devices (Code: JAK)

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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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