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FDA 510(k)

TRULIGHT 5520 AND TRULIGHT 5320

K-Number: K102758 · 2010-10-26

ApplicantTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg
Decision Date2010-10-26
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRULIGHT 5520 AND TRULIGHT 5320 is the device name listed in this FDA 510(k) record. The listed applicant is Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg. It received FDA 510(k) clearance on 2010-10-26 under 510(k) number K102758. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRULIGHT 5520 AND TRULIGHT 5320?

TRULIGHT 5520 AND TRULIGHT 5320 is a medical device that received FDA 510(k) clearance on 2010-10-26. The listed applicant is Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg. The 510(k) number is K102758.

When did TRULIGHT 5520 AND TRULIGHT 5320 receive FDA 510(k) clearance?

TRULIGHT 5520 AND TRULIGHT 5320 received FDA 510(k) clearance on 2010-10-26, under 510(k) number K102758.

Who is the listed applicant for TRULIGHT 5520 AND TRULIGHT 5320?

The FDA 510(k) record lists Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRULIGHT 5520 AND TRULIGHT 5320?

The FDA product code for TRULIGHT 5520 AND TRULIGHT 5320 is FSY.

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Other records listing Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg 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.

K061317ILED

Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK101537AIM 200, MAJOR SURGICAL LIGHTBurton Medical Products Corp.

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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