K202944 is an FDA 510(k) clearance for the NEBULAE SRS Laparoscopic Surgical Smoke Removal System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K202944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |