Product Code: HNB FDA class 1 21 CFR 886.4350

Spoon, Ophthalmic

Ophthalmic

The Ophthalmic Spoon is a small, smooth, spoon-shaped surgical instrument used in ophthalmic procedures such as lens extraction (particularly in extracapsular cataract surgery) or to maneuver delicate ocular tissues during surgery. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without a premarket notification submission. The product code is HNB, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.

510(k)s
0
FEI Numbers
93
Registration Numbers
93
Unique Applicants
0
Years Active

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Basic Information

Product Code
HNB
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

FEI Numbers

This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.