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510(k) K241679

Disposable Cytology Brush (AF series) by Alton (Shanghai) Medical Instruments Co., Ltd. — Product Code KTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2025
Date Received
June 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope Accessory
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Alton (Shanghai) Medical Instruments Co., Ltd.

  • K243039 — Ureteral Stents (AF-D series) (June 18, 2025)
  • K242635 — Endoscopic Distal Attachment (AF-D series) (May 30, 2025)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K231633 — Disposable Hemoclip (AF series) (January 11, 2024)
  • K230925 — Disposable Injection Needle AF series (September 27, 2023)

Other clearances for product code KTI

  • K254040 — LungFlow Basket Catheter (March 12, 2026)
  • K251402 — LIA-1 Catheter (542-1) (December 19, 2025)
  • K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (October 8, 2025)
  • K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA (July 29, 2025)
  • K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)
  • K231818 — METIC™- Airway Balloon Catheter (November 15, 2023)
  • K230778 — EndoCore (September 25, 2023)
  • K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
  • K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)
  • K221206 — Compass Steerable Needle (August 25, 2022)