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EndoCore

by Praxis Medical LLC

EndoCore is an ultrasound aspiration biopsy procedure kit (FDA Class II; FDA product code KTI, Bronchoscope Accessory) made by Praxis Medical LLC, cleared under FDA 510(k) K230778 on 25 Sep 2023 and listed in FDA GUDID since 6 Nov 2025 (UDI-DI 00860003935842), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K230778

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860003935842 UDI-DI Date6 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230778 Date25 Sep 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230778 decided 25 Sep 2023 Active
  • FDA GUDID UDI-DI 00860003935842 listed 6 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230778
  2. Listed FDA GUDID 00860003935842

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ultrasound aspiration biopsy procedure kit
Model / reference
EndoCore
Primary DI / UDI-DI
00860003935842
510(k) Number
FDA product code
KTI
GMDN term
Ultrasound aspiration biopsy procedure kit
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K230778)

and 2 more cleared under K230778

Similar devices

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

Other devices from Praxis Medical LLC

See all devices from Praxis Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)