ReNew XR Handpiece, 25cm, with Reference Markings (3943M) +5 more— 510(k) K234147
Substantially EquivalentMicroline Surgical, Inc.
FDA 510(k) clearance K234147 for ReNew XR Handpiece, 25cm, with Reference Markings (3943M) +5 more, Substantially Equivalent on 2024-04-23. Applicant: Microline Surgical, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Recent devices under product code GEI
view allMore clearances from Microline Surgical, Inc.
view all- K213127 — ReNew Disposable Scissor Tips
- K201884 — ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
- K160706 — ReNew V Handpiece Laparoscopic Instruments
- K152745 — ReNew Sterilization Trays(Catalog #3708 and #3709)
- K152743 — M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.