510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQMClass II

Surgical Smoke Precipitator

21 CFR 878.5050 / General, Plastic Surgery
FDA source (opens on fda.gov)

PQM is the FDA product code for Surgical Smoke Precipitator, a class II device type, regulated under 21 CFR 878.5050. FDA's definition for this code reads: "The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PQM
Device name
Surgical Smoke Precipitator
FDA definition
The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
Regulation
21 CFR 878.5050
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code PQM

By decision year
7 clearances under product code PQM with a decision year between 2016 and 2024, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PQM by decision year
YearClearances
20161
20171
20181
20201
20232
20241

Applicants with the most clearances

Product code PQM
Applicants holding the most 510(k) clearances under product code PQM
ApplicantClearances
Alesi Surgical Ltd7

Companies listing this code with FDA

Companies whose registered establishments list this code