Scissors, Ophthalmic

Device Code: 4226

Product Code(s): HNF

Device Classification Information

Device Type ID4226
Device NameScissors, Ophthalmic
Regulation DescriptionManual Ophthalmic Surgical Instrument.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Intraocular And Corneal Implants Devices Branch (ICIB)
Submission Type510(K) Exempt
CFR Regulation Number886.4350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHNF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4226
DeviceScissors, Ophthalmic
Product CodeHNF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Ophthalmic Surgical Instrument.
CFR Regulation Number886.4350 [🔎]
Device Problems
Break
34
Insufficient Information
1
Inadequate Or Insufficient Training
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 37
TPLC Last Update: 2019-04-02 20:45:07

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