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FDA 510(k)

ENDOSCOUT

K-Number: K033485 · 2004-04-20

ApplicantRobin Medical, Inc.
Decision Date2004-04-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENDOSCOUT is the device name listed in this FDA 510(k) record. The listed applicant is Robin Medical, Inc.. It received FDA 510(k) clearance on 2004-04-20 under 510(k) number K033485. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOUT?

ENDOSCOUT is a medical device that received FDA 510(k) clearance on 2004-04-20. The listed applicant is Robin Medical, Inc.. The 510(k) number is K033485.

When did ENDOSCOUT receive FDA 510(k) clearance?

ENDOSCOUT received FDA 510(k) clearance on 2004-04-20, under 510(k) number K033485.

Who is the listed applicant for ENDOSCOUT?

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

What is the FDA product code for ENDOSCOUT?

The FDA product code for ENDOSCOUT is LNH.

Related Clinical Trials

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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Other records listing Robin Medical, Inc. 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.

K111226ENDOSCOUT TRACKING SYSTEM

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Official Source

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

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