Atlas FDA

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.