Technomed Pulsolith Laser System
FDA 510(k) K895178 · Teknomed, Inc.
510(k) numberK895178
Submission
- Device name
- Technomed Pulsolith Laser System
- Applicant
- Teknomed, Inc.
Danvers, MA, US - Received
- August 10, 1989
- Decision date
- October 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K230488 | EL27-Compact; Sterile EHL-ProbesFFK · Traditional | Walz Elektronik GmbH | 08/31/2023SE |
| K202813 | URO-TOUCH 9 French ProbeFFK · Traditional | Northgate Technologies, Inc. | 06/14/2021SE |
| K191124 | Swiss LithoClast TrilogyFFK · Special | E.M.S Electro Medical Systems S.A | 05/29/2019SE |
| K162119 | UreTron PF Series ProbeFFK · Special | Med-Sonics Corp. | 08/29/2016SE |
| K160198 | UreTron MultiProbe Lithotripter SystemFFK · Special | Med-Sonics Corp. | 02/23/2016SE |
| K132795 | Cyberwand Sterile Probe SetFFK · Special | Cybersonics, Inc. | 11/26/2013SE |
| K130368 | Autolith Touch; Uro TouchFFK · Traditional | Northgate Technologies, Inc. | 11/15/2013SE |
| K123038 | Swiss LithobreakerFFK · Traditional | E.M.S Electro Medical Systems S.A | 01/16/2013SE |
More from E.M.S Electro Medical Systems S.A
| 510(k) | Device | Decision |
|---|---|---|
| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | 05/21/1993SE |
| K920708 | Multilase 2500 aGEX · Traditional | 11/05/1992SE |
| K913917 | Multilase 2100 C, 2100 DGEX · Traditional | 11/05/1992SE |
| K913290 | Multilase 2100 aGEX · Traditional | 02/21/1992SE |
| K890436 | Technomed Pulsolith Laser SystemFFK · Traditional | 03/23/1989SE |
| K790132 | TecnotomoIZF · Traditional | 02/21/1979SE |
Questions and answers
When was Technomed Pulsolith Laser System cleared by the FDA?
Technomed Pulsolith Laser System (K895178) received a 510(k) decision of Substantially Equivalent on October 6, 1989, 57 days after the submission was received.
What is the product code of K895178?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.