Tripter-X1 Series Shockwave Lithotripters
PMA P920034
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP920034 | Date20 Sep 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Tripter-X1 Nova
- Generic Name
- Lithotriptor, extracorporeal shock-wave, urological
- PMA Number
- FDA Product Code
- LNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5990
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Triptor-X1 Series Extracorporeal Shockwave Lithotriptors are medical devices classified as Lithotriptors, Extracorporeal Shock-Wave, Urological under FDA nomenclature. These devices employ high-energy shockwaves to fragment and expel urinary stones, including renal, ureteral, and bladder calculi, without invasive surgical intervention. The technology targets stones through focused acoustic energy, enabling non-invasive treatment for patients with urolithiasis.
The Triptor-X1 Series includes multiple models (Triptor-X1, Triptor-X1 Nova, and Triptor-X1 Compact) and is intended for use in urology and gastroenterology settings. These devices are single-use or reusable (as specified per model) and comply with FDA_PMA approval under PMA number P920034, with regulatory classification as Class II (LNS product code). Sterility and MRI safety specifications are model-dependent, and proper storage conditions must be followed as outlined in the manufacturer’s instructions.
Other devices from Medirex, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of urinary stones can the Triptor-X1 Series be used to treat, and how does it work?
The Triptor-X1 Series is designed to treat renal, ureteral, and bladder calculi (stones) through non-invasive shockwave lithotripsy. It uses focused acoustic energy to fragment stones into smaller pieces that can then be naturally expelled from the urinary system, avoiding the need for invasive surgery.
Are all models of the Triptor-X1 Series single-use, or are some reusable? How should I determine which is appropriate for my facility?
The Triptor-X1 Series includes both single-use and reusable models, with usage specifications varying by model (e.g., Triptor-X1 Nova or Triptor-X1 Compact). Check the manufacturer’s instructions for each specific model to confirm its intended reuse or single-use classification, as this impacts cleaning, sterilization, and maintenance protocols.
What storage conditions must be followed for the Triptor-X1 Series devices to ensure proper functionality and sterility?
Storage conditions are model-dependent, but the manufacturer’s instructions outline requirements to maintain sterility and performance. Typically, this includes protecting devices from moisture, extreme temperatures, and physical damage. Always refer to the provided documentation for precise guidelines.
How do I verify if a Triptor-X1 Series device is compatible with MRI environments, and does this vary by model?
MRI safety specifications for the Triptor-X1 Series vary by model, as noted in the manufacturer’s instructions. To confirm compatibility, consult the device’s technical documentation or contact Medirex, Inc., as some models may not be safe for use in MRI environments due to potential interference or safety risks.
What regulatory approvals apply to the Triptor-X1 Series, and how can I confirm the specific model’s compliance?
The Triptor-X1 Series holds FDA Premarket Approval (PMA) under PMA number P920034, classified as Class II under product code LNS. Each model’s compliance details are documented in the manufacturer’s submission records, which can be referenced via the provided registration numbers or by contacting Medirex, Inc.