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EchoStim ES-20150

by Hakko Co., Ltd.

EchoStim ES-20150 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 May 2019 (UDI-DI 04526737171128), 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) K063380

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 Number04526737171128 UDI-DI Date23 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063380 Date25 Apr 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063380 decided 25 Apr 2007 Active
  • FDA GUDID UDI-DI 04526737171128 listed 23 May 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063380
  2. Listed FDA GUDID 04526737171128

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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-20150
Description
20G x 6"(150mm) Facet tip
Primary DI / UDI-DI
04526737171128
510(k) Number
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
Length — 150 Millimeter
Needle Gauge — 20 Gauge

Related devices

Category: Peripheral anaesthesia single-administration set, non-medicated

Cleared under the same submission (K063380)

and 8 more cleared under K063380

Similar devices

Other devices filed under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)).

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)