Product Code: HNZ FDA class 1 21 CFR 886.4350

Curette, Ophthalmic

Ophthalmic

An Ophthalmic Curette is a surgical scraping instrument used in eye procedures to remove abnormal or unwanted tissue, such as in the treatment of chalazion, corneal lesions, or lid margin disease. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HNZ and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

510(k)s
2
FEI Numbers
122
Registration Numbers
122
Unique Applicants
2
Years Active
3

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Basic Information

Product Code
HNZ
Device Class
FDA class 1
Regulation Number
886.4350
Medical Specialty
Ophthalmic
Review Panel
OP
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K870437 LOOK CAPSULE POLISHERS/SCRAPERS
K841007 OPHTHALMIC CURETTE-VARIOUS

FEI Numbers

This FDA classification entry is associated with 122 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 122 registration numbers. Click on an entry to view related FDA registrations.