Product Code: HNA FDA class 1 21 CFR 886.4350

Spud, Ophthalmic

Ophthalmic

The Ophthalmic Spud is a small, flat-bladed or loop-shaped surgical instrument used to remove superficial corneal foreign bodies, rust rings, or other embedded particles from the eye surface in clinical or emergency settings. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HNA, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.

510(k)s
2
FEI Numbers
92
Registration Numbers
92
Unique Applicants
2
Years Active
6

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Basic Information

Product Code
HNA
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
K931449 MSP OPHTHALMIC (EYE SPUD)
K874963 MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

FEI Numbers

This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.