Clearance Summary
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force received FDA 510(k) clearance under submission number K233351, sponsored by Hg Innovations, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-11-20.
- Submission: K233351
- Applicant / Sponsor: Hg Innovations, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2023-11-20
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.