Surgical Smoke Precipitator

PQM · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.5050

Classification

FDA Product Code: PQM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.5050
Review panel: HO
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown