Suction Pump (SU-90)
FDA 510(k) clearance K260892 · decided 2026-05-14
Clearance details
- K-number
- K260892
- Device name
- Suction Pump (SU-90)
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-18
- Decision date
- 2026-05-14
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.