Piezolith 3000 Triple-Focus Lithotripter
FDA 510(k) K072538 · United Medical Systems, Inc.
510(k) numberK072538
Submission
- Device name
- Piezolith 3000 Triple-Focus Lithotripter
- Applicant
- United Medical Systems, Inc.
Washington, DC, US - Received
- September 7, 2007
- Decision date
- January 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5990
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261086 | Break WaveLNS · Special | Sonomotion, Inc. | 04/29/2026SE |
| K252913 | Break WaveLNS · Traditional | Sonomotion, Inc. | 01/12/2026SE |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200)LNS · Traditional | Shenzhen Wikkon Precision Technologies Co., Ltd. | 06/18/2025SE |
| K221903 | Delta III ProLNS · Traditional | Dornier Medtech America, Inc. | 02/22/2023SE |
| K213772 | LM-9300 Plus LithotripterLNS · Traditional | Lite-Med, Inc. | 01/19/2023SE |
| K201001 | Modulith SLX-F2LNS · Traditional | Karl Storz Endoscopy America | 03/30/2021SE |
| K201074 | Delta III LithotripterLNS · Traditional | Dornier Medtech America, Inc. | 09/03/2020SE |
| K172084 | Delta III LithotripterLNS · Special | Dornier Medtech America, Inc. | 08/08/2017SE |
| K170122 | Delta III LithotripterLNS · Traditional | Dornier Medtech America | 06/28/2017SE |
| K151298 | Gemini XXP-HPLNS · Traditional | Dornier Medtech America | 07/30/2015SE |
More from Dornier Medtech America
| 510(k) | Device | Decision |
|---|---|---|
| K032958 | Piezolith 3000 Lithotripter, Model 3000LNS · Traditional | 02/17/2004SE |
| K894949 | SqaPOV · Traditional | 12/29/1989SE |
| K893003 | Tocolytic Site Care Sup Kit #1001/100A/CARRY CaseFOZ · Traditional | 07/14/1989SESD |
| K863645 | Schulman Double Umbilical Cord Clamp No. 1000HFW · Traditional | 09/25/1986SE |
Questions and answers
When was Piezolith 3000 Triple-Focus Lithotripter cleared by the FDA?
Piezolith 3000 Triple-Focus Lithotripter (K072538) received a 510(k) decision of Substantially Equivalent on January 30, 2008, 145 days after the submission was received.
What is the product code of K072538?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.