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FDA 510(k)

OPHTACATH KIT

K-Number: K123831 · 2013-07-29

ApplicantFrance Chirurgae Instrumentation
Decision Date2013-07-29
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

OPHTACATH KIT is the device name listed in this FDA 510(k) record. The listed applicant is France Chirurgae Instrumentation. It received FDA 510(k) clearance on 2013-07-29 under 510(k) number K123831. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTACATH KIT?

OPHTACATH KIT is a medical device that received FDA 510(k) clearance on 2013-07-29. The listed applicant is France Chirurgae Instrumentation. The 510(k) number is K123831.

When did OPHTACATH KIT receive FDA 510(k) clearance?

OPHTACATH KIT received FDA 510(k) clearance on 2013-07-29, under 510(k) number K123831.

Who is the listed applicant for OPHTACATH KIT?

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

What is the FDA product code for OPHTACATH KIT?

The FDA product code for OPHTACATH KIT is OKS.

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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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