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FDA 510(k)

SELF-RETAINING BICANALICULUS INTUBATON SET II

K-Number: K130375 · 2013-12-04

ApplicantFci Sas (France Chirurgie Instrumentation)
Decision Date2013-12-04
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

SELF-RETAINING BICANALICULUS INTUBATON SET II 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 2013-12-04 under 510(k) number K130375. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF-RETAINING BICANALICULUS INTUBATON SET II?

SELF-RETAINING BICANALICULUS INTUBATON SET II is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Fci Sas (France Chirurgie Instrumentation). The 510(k) number is K130375.

When did SELF-RETAINING BICANALICULUS INTUBATON SET II receive FDA 510(k) clearance?

SELF-RETAINING BICANALICULUS INTUBATON SET II received FDA 510(k) clearance on 2013-12-04, under 510(k) number K130375.

Who is the listed applicant for SELF-RETAINING BICANALICULUS INTUBATON SET II?

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 SELF-RETAINING BICANALICULUS INTUBATON SET II?

The FDA product code for SELF-RETAINING BICANALICULUS INTUBATON SET II is OKS.

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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.

K121142CRAWFORD BIOCANALICULUS INTUBATIONK113536MASTERKA 40 MASTERKA 35 MASTERKA 30

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 SetAnodyneK123831OPHTACATH KITFrance Chirurgae 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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