AccuSert Needle Inserter— 510(k) K213429
Substantially EquivalentEmed Technologies Corporation
FDA 510(k) clearance K213429 for AccuSert Needle Inserter, Substantially Equivalent on 2022-10-20. Applicant: Emed Technologies Corporation.
Clearance details
- Applicant
- Emed Technologies Corporation
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Dorado Hills, CA, US
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
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.