Identity
- Trade Name
- Autolith Touch FDA UDI
- Generic Name
- Electrohydraulic lithotripsy system FDA UDI
- Device Name
- Lithotripter, Biliary, BSC, Demo FDA UDI
- Model / Reference
- M0054668D0 FDA UDI
- Description
- Lithotripter, Biliary, BSC, Demo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817183020530 FDA UDI
- 510(k) Number
- K130368 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Electrohydraulic lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrohydraulic lithotripsy system
Autolith Touch by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrohydraulic lithotripsy system.
- EHL-Probe — Walz Elektronik GmbH · Class II
- EHL-Probe — Walz Elektronik GmbH · Class II
- Electrohydraulic Lithotriptor — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
- Econolith E3000 — Medispec, Ltd. · Class II
- CyberWand — Gyrus Acmi, Inc. · Class II
- EL27-Compact — Walz Elektronik GmbH · Class II
- EHL Probe — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
- CYBERWAND — Gyrus Acmi, Inc. · Class II
Cleared under the same submission
K130368 also covers:
- Autolith Touch — Northgate Technologies Inc.
- Autolith Touch — Northgate Technologies Inc.
- Autolith Touch — Northgate Technologies Inc.
- Autolith Touch — Northgate Technologies Inc.
- Autolith Touch — Northgate Technologies Inc.
- Autolith Touch — Northgate Technologies Inc.
- Autolith Uro-Touch — Northgate Technologies Inc.
- Extender Cable, Autolith Touch — Northgate Technologies Inc.
- Extender Cable, Autolith Touch/Uro-Touch — Northgate Technologies Inc.
- Foot Switch, Autolith Touch — Northgate Technologies Inc.
- Lithotripsy Probe 1.9FR 120cm — Northgate Technologies Inc.
- Lithotripsy Probe 1.9FR 250cm — Northgate Technologies Inc.
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 |
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Manufacturer
- Manufacturer
- Northgate Technologies Inc.
Sources (1)
- FDA UDI 82e5ff95-eccf-41b5-82cc-5dce074bdb9b 34 fields · synced Jun 8, 2026