AirSeal iFS System; AirSeal dV Solution
FDA 510(k) clearance K230239 · decided 2023-09-20
Clearance details
- K-number
- K230239
- Device name
- AirSeal iFS System; AirSeal dV Solution
- Applicant
- Conmed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-01-30
- Decision date
- 2023-09-20
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Utica, NY, US
- Third-party review
- No
- Expedited review
- No
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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 |