inforMED
PUFClass IIImplant

Ocular Peg, Exempt

Ophthalmic · 21 CFR 886.3320

This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time

Recent MDR events

0 adverse event reports on file

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No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

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No data available.

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

0 firms currently registered for this product code

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No registered firms found for this product code.

510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.