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FDA 510(k)

VIT CUTTER MODEL 94

K-Number: K940746 · 1994-06-06

ApplicantVisioncare Devices, Inc.
Decision Date1994-06-06
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VIT CUTTER MODEL 94 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 1994-06-06 under 510(k) number K940746. 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 VIT CUTTER MODEL 94?

VIT CUTTER MODEL 94 is a medical device that received FDA 510(k) clearance on 1994-06-06. The listed applicant is Visioncare Devices, Inc.. The 510(k) number is K940746.

When did VIT CUTTER MODEL 94 receive FDA 510(k) clearance?

VIT CUTTER MODEL 94 received FDA 510(k) clearance on 1994-06-06, under 510(k) number K940746.

Who is the listed applicant for VIT CUTTER MODEL 94?

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 VIT CUTTER MODEL 94?

The FDA product code for VIT CUTTER MODEL 94 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 HANDPIECESK904909I/A VITROPHAGE MODEL YPR 2001

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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