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510(k) K260892

Suction Pump (SU-90) by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
March 18, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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  • K231118 — Cystoscope System (November 13, 2023)
  • K222910 — Bronchoscope System (April 11, 2023)

Other clearances for product code BTA

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  • K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) (April 14, 2026)
  • K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (March 13, 2026)
  • K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (June 6, 2025)
  • K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA61 (May 16, 2025)
  • K251101 — AIRO Suction Unit (AIRO-01) (April 26, 2025)
  • K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) (April 23, 2025)
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