Identifiers
- 510(k) Number
- K914517 FDA 510(k)
- FDA Product Code
- FFK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4480 FDA 510(k)
- Regulation Number
- 876.4480 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SD-200IEHL is an electro-hydraulic lithotriptor device used for stone management in medical procedures. It is designed to break down stones in the body using electro-hydraulic energy, primarily in gastroenterology and urology applications.
This device is supplied by Northgate Technologies Inc. and is FDA 510(k) cleared with product code FFK. It is a reusable device that falls under device class 2, and it is intended for use in clinical settings where stone management procedures are performed.
Frequently asked questions
What is the SD-200IEHL device used for?
The SD-200IEHL is an electro-hydraulic lithotriptor designed to break down stones in the body using electro-hydraulic energy, primarily used in gastroenterology and urology procedures for stone management.
Is the SD-200IEHL a single-use or reusable device?
The SD-200IEHL is a reusable device intended for use in clinical settings where stone management procedures are performed. It is designed to be sterilized and used multiple times.
What is the regulatory status of the SD-200IEHL?
The SD-200IEHL is FDA 510(k) cleared with product code FFK and falls under device class 2. It was cleared on June 30, 1992, with K number K914517.
How is the SD-200IEHL supplied?
The SD-200IEHL is supplied by Northgate Technologies Inc. and is designed for clinical settings where stone management procedures are performed.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SD-200IEHL (TM) 510 (k) K914517 - FDA.report, Home | ntisurgical.com, FDA Product Code FFK - Lithotriptor, Electro-hydraulic, Northgate… — 55 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914517 | Class II | Active |
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Manufacturer
- Manufacturer
- Northgate Technologies Inc.
- FDA Applicant
- Northgate Technologies, Inc.
Sources (1)
- FDA 510(k) K914517 24 fields · synced Oct 1, 2026