EchoStim ES-2180

by Hakko Co., Ltd.

EchoStim ES-2180 is a Class II device made by Hakko Co., Ltd., cleared under FDA 510(k) K063380 on 25 Apr 2007 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04526737170626), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04526737170626 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK063380	Date25 Apr 2007Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04526737170626
FDA 510(k) database 510(k) number K063380

Across registries

2 registries list this device

FDA 510(k) K063380 decided 25 Apr 2007 Active
FDA GUDID UDI-DI 04526737170626 listed 23 Sep 2016 Listed

Timeline

2 dated events

25 Apr 2007 Cleared FDA 510(k) K063380
23 Sep 2016 Listed FDA GUDID 04526737170626

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EchoStim
Generic name: Peripheral anaesthesia single-administration set, non-medicated
Model / reference: ES-2180
Description: 21G x 3 1/8"(80mm) Facet tip

Primary DI / UDI-DI: 04526737170626
510(k) Number: K063380
FDA product code: BSP
GMDN term: Peripheral anaesthesia single-administration set, non-medicated

Device class: Class II
Regulation number: 868.5150
GUDID distribution status: In Commercial Distribution

Size: Needle Gauge — 21 Gauge
Length — 80 Millimeter

Other devices from Hakko Co., Ltd.

See all devices from Hakko Co., Ltd. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)