Sterile single use tip cleaner (WK800-S10 , WK800-S20)
FDA 510(k) clearance K241022 · decided 2024-07-11
Clearance details
- K-number
- K241022
- Device name
- Sterile single use tip cleaner (WK800-S10 , WK800-S20)
- Applicant
- Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2024-04-15
- Decision date
- 2024-07-11
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Huizhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.