Identity
- Trade Name
- EchoStim FDA UDI
- Generic Name
- Peripheral anaesthesia single-administration set, non-medicated FDA UDI
- Device Name
- 20G x 4"(100mm) Facet tip FDA UDI
- Model / Reference
- ES-20100 FDA UDI
- Description
- 20G x 4"(100mm) Facet tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04526737171111 FDA UDI
- 510(k) Number
- K063380 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Peripheral anaesthesia single-administration set, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 20 Gauge FDA UDI
Category: Peripheral anaesthesia single-administration set, non-medicated
EchoStim by Hakko Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral anaesthesia single-administration set, non-medicated.
- Halyard — AVID MEDICAL, INC. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Halyard — AVID MEDICAL, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Halyard — AVID MEDICAL, INC. · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- Halyard — AVID MEDICAL, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K063380 also covers:
- EchoBlock — HAKKO CO., LTD.
- EchoBlock — HAKKO CO., LTD.
- EchoBlock — HAKKO CO., LTD.
- EchoBlock — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoBlock MSK — HAKKO CO., LTD.
- EchoStim — HAKKO CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hakko Co., Ltd.
Sources (1)
- FDA UDI 98be00bf-b086-4fd9-a4f4-d51cfa4e62db 36 fields · synced Jun 8, 2026