AMBIT TUNNELER— 510(k) K110814
Substantially EquivalentSummit Medical Products, Inc.
FDA 510(k) clearance K110814 for AMBIT TUNNELER, Substantially Equivalent on 2011-04-08. Applicant: Summit Medical Products, Inc..
Clearance details
- Applicant
- Summit Medical Products, Inc.
- Product code
- Code BSO
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Salt Lake City, UT, US
Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
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.