Tenderfoot— 510(k) K223352
Substantially EquivalentAccriva Diagnostics, Inc.
FDA 510(k) clearance K223352 for Tenderfoot, Substantially Equivalent on 2023-03-02. Applicant: Accriva Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Accriva Diagnostics, Inc.
- Product code
- Code FMK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code FMK
view allMore clearances from Accriva Diagnostics, Inc.
view all- K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
- K193041 — Hemochron Signature Elite
Adverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
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.