JGH1 Core Deccompression Procedure Kit— 510(k) K181585
Substantially EquivalentAgNovos Healthcare USA, LLC
FDA 510(k) clearance K181585 for JGH1 Core Deccompression Procedure Kit, Substantially Equivalent on 2018-07-20. Applicant: AgNovos Healthcare USA, LLC.
Clearance details
- Applicant
- AgNovos Healthcare USA, LLC
- Product code
- Code MQV
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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.