EndoCore

510(k) Number

K230778 ↗

FDA product code

KTI

FDA applicant

Praxis Medical, LLC

Device class

Class II

Regulation

21 CFR Part 874.4680

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code KTI (Bronchoscope Accessory).

• Compass Steerable Needle by SERPEX MEDICAL, INC.
• CONMED 001429 by Conmed Corporation
• Defendo Bronchoscopy Suction Valve by MEDIVATORS INC.
• Andorate Suction Valve and Andorate Biopsy Valve by GA HEALTH COMPANY LIMITED
• aeris Balloon Dialation Catheter by BRYAN MEDICAL INC.
• Cook G09727 C-RETRO-6.0-50-38J-110 by COOK INCORPORATED
• AIRWAY BALLOON CATHETER INFLATION DEVICE by ACCLARENT, INC.
• Endo Bite Block by American Endoscopy, Inc.
• Disposable Grasping Forceps FG-52D/FG-54D by Olympus Medical Systems Corporation
• Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 by SERPEX MEDICAL, INC.

• Monarch Pouch BV ENDO-BV-22G-M

  Class II

  FDA 510(k) K230778 Active Cleared 25 Sep 2023 GUDID on market

• Ion Pouch FR ENDO-FR-22G-I

  Class II

  FDA 510(k) K230778 Active Cleared 25 Sep 2023 GUDID on market

• Monarch Pouch FR ENDO-FR-22G-M

  Class II

  FDA 510(k) K230778 Active Cleared 25 Sep 2023 GUDID on market

• Olympus Pouch BV ENDO-BV-22G-O

  Class II

  FDA 510(k) K230778 Active Cleared 25 Sep 2023 GUDID on market

See all devices from Praxis Medical LLC →