Cleared Traditional

NEBULAE SRS Laparoscopic Surgical Smoke Removal System

K202944 · Northgate Technologies, Inc. · General Hospital
Mar 2021
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K202944 is an FDA 510(k) clearance for the NEBULAE SRS Laparoscopic Surgical Smoke Removal System, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on March 25, 2021, 176 days after receiving the submission on September 30, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K202944 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2020
Decision Date March 25, 2021
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYD — Apparatus, Exhaust, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5070

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