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FDA 510(k)

AXCEL SURGICAL LIGHT

K-Number: K030906 · 2003-04-23

ApplicantAlm
Decision Date2003-04-23
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXCEL SURGICAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Alm. It received FDA 510(k) clearance on 2003-04-23 under 510(k) number K030906. 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 AXCEL SURGICAL LIGHT?

AXCEL SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 2003-04-23. The listed applicant is Alm. The 510(k) number is K030906.

When did AXCEL SURGICAL LIGHT receive FDA 510(k) clearance?

AXCEL SURGICAL LIGHT received FDA 510(k) clearance on 2003-04-23, under 510(k) number K030906.

Who is the listed applicant for AXCEL SURGICAL LIGHT?

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

What is the FDA product code for AXCEL SURGICAL LIGHT?

The FDA product code for AXCEL SURGICAL LIGHT is FSY.

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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. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

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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