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FDA 510(k)

MASTERKA 40 MASTERKA 35 MASTERKA 30

K-Number: K113536 · 2012-08-03

ApplicantFci Sas (France Chirurgie Instrumentation)
Decision Date2012-08-03
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

MASTERKA 40 MASTERKA 35 MASTERKA 30 is the device name listed in this FDA 510(k) record. The listed applicant is Fci Sas (France Chirurgie Instrumentation). It received FDA 510(k) clearance on 2012-08-03 under 510(k) number K113536. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERKA 40 MASTERKA 35 MASTERKA 30?

MASTERKA 40 MASTERKA 35 MASTERKA 30 is a medical device that received FDA 510(k) clearance on 2012-08-03. The listed applicant is Fci Sas (France Chirurgie Instrumentation). The 510(k) number is K113536.

When did MASTERKA 40 MASTERKA 35 MASTERKA 30 receive FDA 510(k) clearance?

MASTERKA 40 MASTERKA 35 MASTERKA 30 received FDA 510(k) clearance on 2012-08-03, under 510(k) number K113536.

Who is the listed applicant for MASTERKA 40 MASTERKA 35 MASTERKA 30?

The FDA 510(k) record lists Fci Sas (France Chirurgie Instrumentation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTERKA 40 MASTERKA 35 MASTERKA 30?

The FDA product code for MASTERKA 40 MASTERKA 35 MASTERKA 30 is OKS.

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 Fci Sas (France Chirurgie Instrumentation) 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.

K130375SELF-RETAINING BICANALICULUS INTUBATON SET IIK121142CRAWFORD BIOCANALICULUS INTUBATION

Related Devices (Code: OKS)

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.

K201892Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) SasK201606LacriJet®Fci (France Chirurgie Instrumentation) SasK170247Lacriflow CLKaneka Pharma America, LLCK161373NunchakuFci (France Chirurgie Instrumentation)K160710Oasis Lacrimal Intubation SetAnodyneK130375SELF-RETAINING BICANALICULUS INTUBATON SET IIFci Sas (France Chirurgie Instrumentation)

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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