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510(k) K252874

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 by Serpex Medical, Inc. — Product Code KTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2025
Date Received
September 10, 2025
Clearance Type
Special
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 Serpex Medical, Inc.

  • K221206 — Compass Steerable Needle (August 25, 2022)
  • K221302 — Recon Steerable Sheath (August 15, 2022)

Other clearances for product code KTI

  • K254040 — LungFlow Basket Catheter (March 12, 2026)
  • K251402 — LIA-1 Catheter (542-1) (December 19, 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)
  • K241679 — Disposable Cytology Brush (AF series) (March 4, 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)