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FDA 510(k)

TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES

K-Number: K053413 · 2006-04-06

Decision Date2006-04-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2006-04-06 under 510(k) number K053413. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES?

TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES is a medical device that received FDA 510(k) clearance on 2006-04-06. The listed applicant is Terumo Europe N.V.. The 510(k) number is K053413.

When did TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES receive FDA 510(k) clearance?

TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES received FDA 510(k) clearance on 2006-04-06, under 510(k) number K053413.

Who is the listed applicant for TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES?

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

What is the FDA product code for TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES?

The FDA product code for TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES is FMF.

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.

Other records listing Terumo Europe N.V. 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: FMF)

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.

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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