EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
FDA 510(k) clearance K181127 · decided 2019-01-03
Clearance details
- K-number
- K181127
- Device name
- EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
- Applicant
- Interscope, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-30
- Decision date
- 2019-01-03
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- PTE
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Whitinsville, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EndoRotor (K170120) | Interscope, Inc. | 2017-04-18 |
Recalls involving this device
No recalls on record reference this clearance.