CORE E3 Suction/irrigator
FDA 510(k) clearance K202303 · decided 2021-02-19
Clearance details
- K-number
- K202303
- Device name
- CORE E3 Suction/irrigator
- Applicant
- Conmed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-08-14
- Decision date
- 2021-02-19
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Utica, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Conmed Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |