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FDA 510(k)

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT

K-Number: K133425 · 2013-12-05

ApplicantEngineered Medical Solutions Co., LLC
Decision Date2013-12-05
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Solutions Co., LLC. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K133425. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT?

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is Engineered Medical Solutions Co., LLC. The 510(k) number is K133425.

When did SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT receive FDA 510(k) clearance?

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT received FDA 510(k) clearance on 2013-12-05, under 510(k) number K133425.

Who is the listed applicant for SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT?

The FDA 510(k) record lists Engineered Medical Solutions Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT?

The FDA product code for SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT is FTD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Engineered Medical Solutions Co., LLC 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.

K071180SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

Related Devices (Code: FTD)

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.

K130513VOLISTA 400; VOLISTA 600Maquet S.A.S.K123776POLARIS 100/200Drager Medical GmbHK111020ATRICURE DISSECTORAtriCure, Inc.K100234HM-LAMP IIHillusa, Inc.K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.K071180SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001Engineered Medical Solutions Co., LLC

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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