FDA Product Code
FDA Product Code PTE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1690
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | Interscope, Inc. | 2019-01-03 | Traditional | PDF ↗ |
| K170120 | EndoRotor | Interscope, Inc. | 2017-04-18 | Traditional | PDF ↗ |
Product code PTE · Class II · Obstetrics/Gynecology. Data: openFDA.