Tripter X-1 Compact Duet
FDA 510(k) K023535 · Direx Systems Corp.
510(k) numberK023535
Submission
- Device name
- Tripter X-1 Compact Duet
- Applicant
- Direx Systems Corp.
Natick, MA, US - Received
- October 21, 2002
- Decision date
- January 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K242922 | Extracorporeal Shock Wave Lithotripter (U200)LNS · Traditional | Shenzhen Wikkon Precision Technologies Co., Ltd. | 06/18/2025SE |
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| 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 |
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Questions and answers
When was Tripter X-1 Compact Duet cleared by the FDA?
Tripter X-1 Compact Duet (K023535) received a 510(k) decision of Substantially Equivalent on January 17, 2003, 88 days after the submission was received.
What is the product code of K023535?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.