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FDA 510(k)

I/A VITROPHAGE MODEL YPR 2001

K-Number: K904909 · 1991-01-28

ApplicantVisioncare Devices, Inc.
Decision Date1991-01-28
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

I/A VITROPHAGE MODEL YPR 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Visioncare Devices, Inc.. It received FDA 510(k) clearance on 1991-01-28 under 510(k) number K904909. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I/A VITROPHAGE MODEL YPR 2001?

I/A VITROPHAGE MODEL YPR 2001 is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is Visioncare Devices, Inc.. The 510(k) number is K904909.

When did I/A VITROPHAGE MODEL YPR 2001 receive FDA 510(k) clearance?

I/A VITROPHAGE MODEL YPR 2001 received FDA 510(k) clearance on 1991-01-28, under 510(k) number K904909.

Who is the listed applicant for I/A VITROPHAGE MODEL YPR 2001?

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

What is the FDA product code for I/A VITROPHAGE MODEL YPR 2001?

The FDA product code for I/A VITROPHAGE MODEL YPR 2001 is HQE.

Related Clinical Trials

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.

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Other records listing Visioncare Devices, 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.

K120170PROCARE PLUS VITRECTOMY SYSTEMK023939VELOCITY ADVANTAGEK971064BAYERS BIMANUAL I/A HANDPIECESK940746VIT CUTTER MODEL 94

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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