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FDA 510(k)

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

K-Number: K061404 · 2006-08-07

ApplicantFci Ophthalmics, Inc.
Decision Date2006-08-07
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Fci Ophthalmics, Inc.. It received FDA 510(k) clearance on 2006-08-07 under 510(k) number K061404. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE?

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE is a medical device that received FDA 510(k) clearance on 2006-08-07. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K061404.

When did MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE receive FDA 510(k) clearance?

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE received FDA 510(k) clearance on 2006-08-07, under 510(k) number K061404.

Who is the listed applicant for MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE?

The FDA 510(k) record lists Fci Ophthalmics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE?

The FDA product code for MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE is OKS.

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Other records listing Fci Ophthalmics, Inc. 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.

K061398SNUG PLUG PUNCTUM PLUGK041869SELF RETAINING BICANALICULUS INTUBATION SETK023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTK030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESK992294BIOCERAMIC ORBITAL IMPLANT

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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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