inforMED
PQMClass II

Surgical Smoke Precipitator

General, Plastic Surgery · 21 CFR 878.5050

The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.

MDR events4All time
Recalls0All time
Registered firms11Currently listed
510(k) clearances7All time

Recent MDR events

4 adverse event reports on file

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Event type breakdown

Malfunction4

Most-reported manufacturers

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Dexcom, Inc.4

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

11 firms currently registered for this product code

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510(k) clearances

7 clearances for this product code

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