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510(k) K243138

Geon (S2) Nasal Aspirator by Geon Corporation — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2025
Date Received
September 30, 2024
Clearance Type
Special
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

Other clearances by Geon Corporation

  • K220126 — Geonic Nasal Aspirator, Geonic Nasal Cleaner (February 2, 2023)
  • K100563 — GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA (June 2, 2010)

Other clearances for product code BTA

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  • 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)
  • K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose sys (March 7, 2025)
  • K241852 — Nasal Aspirator (NS 13) (December 31, 2024)
  • K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (November 19, 2024)
  • K241202 — Electric nasal aspirator (HTD2601US) (July 1, 2024)
  • K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009 (March 20, 2024)
  • K232831 — Quiver Aspiration Pump (February 22, 2024)