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FDA 510(k)

VISUM BLADE LED SURGICAL LIGHTING SYSTEM

K-Number: K132747 · 2013-12-30

ApplicantStryker Communications
Decision Date2013-12-30
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISUM BLADE LED SURGICAL LIGHTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Communications. It received FDA 510(k) clearance on 2013-12-30 under 510(k) number K132747. 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 VISUM BLADE LED SURGICAL LIGHTING SYSTEM?

VISUM BLADE LED SURGICAL LIGHTING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-30. The listed applicant is Stryker Communications. The 510(k) number is K132747.

When did VISUM BLADE LED SURGICAL LIGHTING SYSTEM receive FDA 510(k) clearance?

VISUM BLADE LED SURGICAL LIGHTING SYSTEM received FDA 510(k) clearance on 2013-12-30, under 510(k) number K132747.

Who is the listed applicant for VISUM BLADE LED SURGICAL LIGHTING SYSTEM?

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

What is the FDA product code for VISUM BLADE LED SURGICAL LIGHTING SYSTEM?

The FDA product code for VISUM BLADE LED SURGICAL LIGHTING SYSTEM is FSY.

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 Stryker Communications 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.

K100852STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000

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.

K132307VIDA 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.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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