Last synced on 14 November 2025 at 11:06 pm

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)

Page Type
Cleared 510(K)
510(k) Number
K234147
510(k) Type
Traditional
Applicant
Microline Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2024
Days to Decision
116 days
Submission Type
Summary

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)

Page Type
Cleared 510(K)
510(k) Number
K234147
510(k) Type
Traditional
Applicant
Microline Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2024
Days to Decision
116 days
Submission Type
Summary