Autolith Touch; Uro Touch
FDA 510(k) K130368 · Northgate Technologies, Inc.
510(k) numberK130368
Submission
- Device name
- Autolith Touch; Uro Touch
- Applicant
- Northgate Technologies, Inc.
Elgin, IL, US - Received
- February 14, 2013
- Decision date
- November 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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| K022052 | 40LPM Abdominal Insufflator, Catalog # 72-00203-0HIF · Traditional | 01/24/2003SE |
| K010053 | Humi-Flow, Model 6-850-00/ 01/02HIF · Traditional | 10/23/2001SE |
| K011928 | Hydrotower Arthroscopic Administration Tubing Set, Model 7-460-05FPA · Traditional | 08/10/2001SE |
| K001325 | Flo Assistant, Model 4-250-00LJH · Traditional | 08/18/2000SE |
| K993778 | Hydrotower Management System, Model 4-750-00OCX · Special | 01/06/2000SE |
Questions and answers
When was Autolith Touch; Uro Touch cleared by the FDA?
Autolith Touch; Uro Touch (K130368) received a 510(k) decision of Substantially Equivalent on November 15, 2013, 274 days after the submission was received.
What is the product code of K130368?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.