Gemini XXP-HP
FDA 510(k) K151298 · Dornier Medtech America
510(k) numberK151298
Submission
- Device name
- Gemini XXP-HP
- Applicant
- Dornier Medtech America
Kennesaw, GA, US - Received
- May 15, 2015
- Decision date
- July 30, 2015
- 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
| 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 |
| K142561 | LM-9300 ELMA LithotripterLNS · Abbreviated | Lite-Med, Inc. | 03/20/2015SE |
More from Lite-Med, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…FED · Traditional | 01/31/2025SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | 06/26/2024SE |
| K221903 | Delta III ProLNS · Traditional | 02/22/2023SE |
| K213252 | Dornier ThulioGEX · Traditional | 07/27/2022SE |
| K220871 | NautilusJAA · Special | 04/18/2022SE |
| K210394 | Electrosurgical accessoryFAS · Traditional | 05/19/2021SE |
| K201815 | Dornier MAGELLAN Ureteral Access SheathFED · Traditional | 11/20/2020SE |
| K201074 | Delta III LithotripterLNS · Traditional | 09/03/2020SE |
| K190612 | EQUINOX Balloon Dilatation CatheterEZN · Traditional | 12/06/2019SE |
| K190312 | Dornier Ureteral StentFAD · Traditional | 11/15/2019SE |
Questions and answers
When was Gemini XXP-HP cleared by the FDA?
Gemini XXP-HP (K151298) received a 510(k) decision of Substantially Equivalent on July 30, 2015, 76 days after the submission was received.
What is the product code of K151298?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.