K242664
- 510(k) number
- K242664
- Device name
- gentleheel® Adult Incision Device
- Applicant
- Gri-Alleset, Inc. GA · US
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2024-11-05
- Date received
- 2024-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242664.pdf
Official FDA record: K242664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.