K234147

ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)

510(k) number: K234147
Device name: ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)
Applicant: Microline Surgical, Inc. MA · US
Product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date: 2024-04-23
Date received: 2023-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 5.9 MB · U.S. public domain

Also available from FDA: K234147.pdf

Official FDA record: K234147

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.