Twinheads TH-101 Extracorporeal Shock Wave Lithotripter
FDA 510(k) K030346 · Fmd, LLC
510(k) numberK030346
Submission
- Device name
- Twinheads TH-101 Extracorporeal Shock Wave Lithotripter
- Applicant
- Fmd, LLC
Redmond, WA, US - Received
- February 3, 2003
- Decision date
- May 2, 2003
- 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
Other 510(k)s with product code LNS
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|---|---|---|---|
| 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 |
|---|---|---|
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | 03/20/2026SE |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)DQX · Special | 06/13/2024SE |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTDQX · Traditional | 05/27/2022SE |
| K042561 | Twinheads TH-103 Extracorporeal Shock Wave LithotripterLNS · Special | 10/12/2004SE |
Questions and answers
When was Twinheads TH-101 Extracorporeal Shock Wave Lithotripter cleared by the FDA?
Twinheads TH-101 Extracorporeal Shock Wave Lithotripter (K030346) received a 510(k) decision of Substantially Equivalent on May 2, 2003, 88 days after the submission was received.
What is the product code of K030346?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.