gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler— 510(k) K220917

Substantially Equivalent

Gri-Alleset, Inc.

FDA 510(k) clearance K220917 for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler, Substantially Equivalent on 2022-05-18. Applicant: Gri-Alleset, Inc..

Clearance details

Applicant: Gri-Alleset, Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2022-03-30
Decision date: 2022-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowery Branch, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.