DeviceClearance

Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more— 510(k) K261959

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K261959 for Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more, Substantially Equivalent on 2026-09-17. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Device name as filed
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)
Applicant
Stryker Instruments
Product code
Code GEI
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Portage, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEI

product code GEI
Death
133
Injury
7,585
Malfunction
35,808
Other
44
Total
43,570

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.