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FDA 510(k)

ULTRACLIP II US

K-Number: K042341 · 2004-09-20

ApplicantInrad
Decision Date2004-09-20
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRACLIP II US is the device name listed in this FDA 510(k) record. The listed applicant is Inrad. It received FDA 510(k) clearance on 2004-09-20 under 510(k) number K042341. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACLIP II US?

ULTRACLIP II US is a medical device that received FDA 510(k) clearance on 2004-09-20. The listed applicant is Inrad. The 510(k) number is K042341.

When did ULTRACLIP II US receive FDA 510(k) clearance?

ULTRACLIP II US received FDA 510(k) clearance on 2004-09-20, under 510(k) number K042341.

Who is the listed applicant for ULTRACLIP II US?

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

What is the FDA product code for ULTRACLIP II US?

The FDA product code for ULTRACLIP II US is NEU.

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Other records listing Inrad 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: NEU)

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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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