Product Code: MXY FDA class 1 21 CFR 886.4350

Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal

Ophthalmic

The Ophthalmic Posterior Capsular Polishing Cannula made of Polyvinyl Acetal is a surgical instrument used during cataract surgery to polish the posterior lens capsule, removing residual epithelial cells to reduce the incidence of posterior capsule opacification. Classified as FDA Class 1, it is subject to general controls under regulation 886.4350 (Ophthalmic specialty). As a low-risk surgical instrument, it is not GMP-exempt but requires only general controls.

510(k)s
0
FEI Numbers
42
Registration Numbers
42
Unique Applicants
0
Years Active

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Basic Information

Product Code
MXY
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 42 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.