Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
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.
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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
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.