Skip to content

EndoClot Applicator EA230

by EndoClot Plus Co., Ltd.

EndoClot Applicator EA230 is a Class II device made by EndoClot Plus Co., Ltd., cleared under FDA 510(k) K162197 on 18 Jan 2017 and listed in FDA GUDID since 23 Jun 2021 (UDI-DI 16972011720110), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K162197

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16972011720110 UDI-DI Date23 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK162197 Date18 Jan 2017IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162197 decided 18 Jan 2017 Active
  • FDA GUDID UDI-DI 16972011720110 listed 23 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162197
  2. Listed FDA GUDID 16972011720110

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EndoClot Applicator
Generic name
Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Model / reference
EA230
Primary DI / UDI-DI
16972011720110
510(k) Number
FDA product code
GCJ
GMDN term
Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from EndoClot Plus Co., Ltd.

See all devices from EndoClot Plus Co., Ltd. →

Properties

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