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FDA 510(k)

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

K-Number: K030054 · 2003-02-26

ApplicantFci Ophthalmics, Inc.
Decision Date2003-02-26
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES 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 2003-02-26 under 510(k) number K030054. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES?

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K030054.

When did DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES receive FDA 510(k) clearance?

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES received FDA 510(k) clearance on 2003-02-26, under 510(k) number K030054.

Who is the listed applicant for DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES?

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 DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES?

The FDA product code for DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES is HJK.

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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.

K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEK061398SNUG PLUG PUNCTUM PLUGK041869SELF RETAINING BICANALICULUS INTUBATION SETK023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTK992294BIOCERAMIC ORBITAL IMPLANT

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Related Devices (Code: HJK)

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.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

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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