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FDA 510(k)

MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS

K-Number: K030353 · 2003-04-25

ApplicantEagle Vision, Inc.
Decision Date2003-04-25
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Vision, Inc.. It received FDA 510(k) clearance on 2003-04-25 under 510(k) number K030353. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS?

MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS is a medical device that received FDA 510(k) clearance on 2003-04-25. The listed applicant is Eagle Vision, Inc.. The 510(k) number is K030353.

When did MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS receive FDA 510(k) clearance?

MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS received FDA 510(k) clearance on 2003-04-25, under 510(k) number K030353.

Who is the listed applicant for MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS?

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

What is the FDA product code for MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS?

The FDA product code for MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS is OKS.

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Other records listing Eagle Vision, 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.

K053333EAGLEVISION GELLANSERTS, MODEL REF 0040K991130FLEXPLUGK905427EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUGK890919TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTK890920EAGLE VISION-FREEMAN(TM) PUNCTAL VALVEK883233EV MONOCANALICULAR STENT (TM)

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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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