Piezolith 3000 Lithotripter, Model 3000
FDA 510(k) K032958 · United Medical Systems, Inc.
510(k) numberK032958
Submission
- Device name
- Piezolith 3000 Lithotripter, Model 3000
- Applicant
- United Medical Systems, Inc.
Washington, DC, US - Received
- September 22, 2003
- Decision date
- February 17, 2004
- 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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| K170122 | Delta III LithotripterLNS · Traditional | Dornier Medtech America | 06/28/2017SE |
| K151298 | Gemini XXP-HPLNS · Traditional | Dornier Medtech America | 07/30/2015SE |
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| K072538 | Piezolith 3000 Triple-Focus LithotripterLNS · Traditional | 01/30/2008SE |
| 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 Lithotripter, Model 3000 cleared by the FDA?
Piezolith 3000 Lithotripter, Model 3000 (K032958) received a 510(k) decision of Substantially Equivalent on February 17, 2004, 148 days after the submission was received.
What is the product code of K032958?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.