FDA cleared the 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) from Stryker Instruments on Sep 17, 2026 under K261959, a special 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Jun 11, 2026. The decision came 98 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Stryker Instruments has 3 other decisions in the tracker over the last 12 months: K261544 (Hydro Irrigation System), K253679 (Hydro Irrigation System), K252282 (SurgiCount+ System).
Questions & Answers
What did FDA clear under K261959?
K261959 is the FDA 510(k) for 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), submitted by Stryker Instruments. FDA's decision date was Sep 17, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).
Who makes the 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)?
Stryker Instruments, based in Portage, MI, is the applicant of record for K261959.
How long did the K261959 review take?
FDA received the submission on Jun 11, 2026 and issued its decision on Sep 17, 2026, 98 days later.