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510(k) K230778

EndoCore by Praxis Medical, LLC — Product Code KTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2023
Date Received
March 21, 2023
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 Praxis Medical, LLC

  • K200278 — CytoCore (March 31, 2020)

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  • 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)