EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand— 510(k) K190715
Substantially EquivalentInterscope, Inc.
FDA 510(k) clearance K190715 for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand, Substantially Equivalent on 2019-12-13. Applicant: Interscope, Inc.. Device class: 2.
Clearance details
- Applicant
- Interscope, Inc.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whitinsville, MA, US
Recent devices under product code ERL
view allMore clearances from Interscope, Inc.
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.