LAP-iX Suction Irrigation
FDA 510(k) clearance K200638 · decided 2020-04-03
Clearance details
- K-number
- K200638
- Device name
- LAP-iX Suction Irrigation
- Applicant
- Sejong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-10
- Decision date
- 2020-04-03
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Paju-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.