Device Listing 1076535539
Listing Summary#
- Listing key
- 1076535539
- Premarket submission
- K234147
- Device
- 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.
- Product code
- GEI
- Decision date
- 2024-04-23