ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm— 510(k) K201884

Substantially Equivalent

Microline Surgical, Inc.

FDA 510(k) clearance K201884 for ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm, Substantially Equivalent on 2020-10-21. Applicant: Microline Surgical, Inc..

Clearance details

Applicant: Microline Surgical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2020-07-08
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

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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, 2020-01-01 through 2026-04-23. 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.