Zenflow Spring Implant and Delivery System
by Zenflow, Inc. PMA
Active
PMA P250007
Overview
The Zenflow Spring Implant and Delivery System is classified as a Stent, Urethral, Prostatic, Permanent or Semi-Permanent, designed to relieve obstructive lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). This device is intended for men with prostatic urethral lengths between 25 and 45 mm and prostate volumes between 25 and 80 cc, providing mechanical support to the urethra without surgical excision of prostate tissue.
The system is delivered via a catheter-based approach and is intended for permanent or semi-permanent implantation. It is supplied sterile and intended for single-use, with no explicit MRI safety restrictions noted in the data. The device carries an FDA PMA approval (P250007) and is regulated under Class III classification. Storage and handling follow standard sterile medical device protocols as defined by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP250007 | Date11 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- PMA Number
- FDA Product Code
- MER
- Device Class
- Class III
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APPR Approved
Other devices from Zenflow, Inc.
Questions
What specific patient measurements determine if someone is a candidate for the Zenflow Spring Implant and Delivery System?
The Zenflow Spring Implant is designed for men with prostatic urethral lengths between **25 and 45 mm** and prostate volumes between **25 and 80 cc**. These measurements help ensure the device can provide appropriate mechanical support to relieve obstructive lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH).
Is the Zenflow Spring Implant and Delivery System intended for temporary use, or is it meant to remain in place long-term?
The device is classified as a **permanent or semi-permanent** urethral stent, meaning it is intended to remain implanted for an extended duration to maintain urethral support. It is not designed for short-term or temporary use.
How is the Zenflow Spring Implant and Delivery System supplied, and what are the key handling considerations?
The system is supplied **sterile** and intended for **single-use only**. It follows standard sterile medical device protocols for storage and handling, as outlined by the manufacturer, to ensure safety and efficacy before and during use.
Are there any known restrictions on using the Zenflow Spring Implant in patients who require MRI scans?
The provided data does not explicitly mention **MRI safety restrictions** for the Zenflow Spring Implant. However, as with any implanted device, clinicians should verify compatibility with MRI procedures on a case-by-case basis or consult the manufacturer’s guidelines.
What regulatory pathway was followed for the Zenflow Spring Implant and Delivery System, and what class does it fall under?
The device underwent **FDA Premarket Approval (PMA)** under the classification of **Class III**, which is required for higher-risk medical devices. The approval number is **P250007**, confirming its regulatory status as a permanent or semi-permanent urethral stent.