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Endoch EAI-0817

by Endoch Inc

Endoch EAI-0817 is a Class II device made by Endoch Inc, cleared under FDA 510(k) K171825 on 13 Feb 2018 and listed in FDA GUDID since 1 Jun 2019 (UDI-DI EAI0817), active as of 23 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 23 Oct 2026

Documents

510(k) K171825

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEAI0817 UDI-DI Date1 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171825 Date13 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171825 decided 13 Feb 2018 Active
  • FDA GUDID UDI-DI EAI0817 listed 1 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171825
  2. Listed FDA GUDID EAI0817

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endoch
Generic name
Invasive blood pressure monitoring damping device
Model / Ref / Catalog
EAI-0817
Primary DI / UDI-DI
EAI0817
510(k) Number
FDA product code
GEI, JOK
GMDN term
Invasive blood pressure monitoring damping device
Device class
Class II
Regulation number
878.4400, 880.6820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Invasive blood pressure monitoring damping device

Cleared under the same submission (K171825)

and 8 more cleared under K171825

Other devices from Endoch Inc

See all devices from Endoch Inc →

Properties

  • Supplied sterile
Other properties (14, all answered No)