Device
The Device is an end-piece smoke collector to be used as an alternative to the standard plastic "wand" smoke collector in current use with smoke evacuation Systems for laser surgic...
Manufacturer
NASCENT SURGICAL, LLC
NASCENT SURGICAL, LLC
Model: SQ20012-03
DI: 10860012888822
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
The Device is an end-piece smoke collector to be used as an alternative to the standard plastic "wand" smoke collector in current use with smoke evacuation Systems for laser surgical procedures (Smoke evacuation system, Laser; classification number, 79VCN; docket: none). Specifically, the Device is an end-piece smoke collector to be attached to laser plume evacuation systems currently in use. The Device is used by attaching it to the same type of sterile hose to which the wand-type smoke collector is attached, as currently used in laser plume evacuation Systems. The Device is disposed of after each use. The Device is manufactured in three sizes, all of which have the same function and intended use.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f019e538-a014-4dfa-844f-03f2463c8e81
Distribution Status:
In Commercial Distribution
DUNS Number:
047059499
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10860012888822
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44979
Name: Surgical plume evacuation system filter
Definition:
A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).
FDA Product Codes
FYD
Apparatus, Exhaust, Surgical
Premarket Submissions
Submission Number:
K894038
Supplement Number:
000