Hmt Shock Plug/Lithotripter Electrode
PMA P870011
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP870011 | Date6 Sep 1990 | 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- Withdrawn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
- 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
This device is an extracorporeal shock-wave lithotriptor, designed for the non-invasive fragmentation of urological calculi (kidney or ureteral stones) using high-energy shock waves. It operates by delivering focused acoustic pulses to target stones, facilitating their breakdown into smaller, more manageable particles for natural excretion or subsequent removal.
The HMT Shock Plug/Lithotriptor Electrode is supplied as a reusable component within a lithotripsy system, intended for use in urology and gastroenterology settings. It requires sterile preparation per manufacturer instructions and is regulated under FDA Premarket Approval (PMA P870011) as a Class II device (product code LNS). Storage and handling must comply with facility protocols to ensure device integrity and patient safety.
Questions
AI-generated answers, 18 Sep 2026
What clinical specialties is this device primarily intended for, and how does it function in those settings?
The HMT Shock Plug/Lithotriptor Electrode is designed for use in urology and gastroenterology settings, as indicated by its advisory committee classification (GU). It is part of an extracorporeal shock-wave lithotripsy system, which means it delivers high-energy acoustic pulses to break down kidney or ureteral stones (calculi) non-invasively. The shock waves fragment the stones into smaller particles, allowing them to be naturally excreted or removed more easily, reducing the need for surgical intervention.
Is the HMT Shock Plug/Lithotriptor Electrode a single-use or reusable device, and what preparation is required before use?
The HMT Shock Plug/Lithotriptor Electrode is reusable as part of the lithotripsy system. Before use, it must be sterilized according to the manufacturer’s instructions to ensure patient safety and device integrity. Proper sterile preparation is critical, as the device is not pre-sterilized for single-use.
What regulatory pathway does this device follow, and what does that mean for its use in clinical practice?
This device follows the FDA Premarket Approval (PMA) pathway, granted under PMA number P870011 and classified as a Class II device (product code LNS). This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use—fragmenting urological calculi via extracorporeal shock waves. Clinicians can rely on this approval as evidence of the device’s regulatory validation for use in urology and gastroenterology.
How should the HMT Shock Plug/Lithotriptor Electrode be stored, and what considerations should facilities keep in mind?
While the device specifications do not detail exact storage conditions, facilities must adhere to manufacturer-provided protocols to maintain its integrity and functionality. Since it is reusable and requires sterile preparation, storage areas should be clean, protected from contamination, and follow standard medical device handling guidelines. Proper maintenance ensures the electrode remains effective for repeated use in lithotripsy procedures.