FDA cleared the HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) from Ethicon Endo-Surgery, LLC on Sep 17, 2026 under K254196, a traditional 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 Dec 23, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Ethicon Endo-Surgery, LLC has 3 other decisions in the tracker over the last 12 months: K260196 (ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)), K252906 (ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)), K252739 (ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)).