Data / Medical devices / United States / Zenflow, Inc.
Zenflow, Inc.: FDA-registered device maker in South San Francisco, CA, United States, 1 510(k) clearance and 1 PMA approval
Zenflow, Inc. is registered with the FDA (registration 3014211785) in South San Francisco, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014211785
- Address
- 395 Oyster Point Blvd. Suite 501, South San Francisco, CA, United States, 94080
- Owner or operator
- Zenflow, Inc. (10056580)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 19, 2026
- Registered through
- 2026
- Brand names listed
- Zenflow Camera Control Unit, Zenflow Spring Implant Retrieval Device, Zenflow Spring Implant and Delivery System, Zenflow Spring Scope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | MER | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2025 | K251140 | Zenflow Spring Scope | FAJ | Substantially Equivalent | Zenflow, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 11, 2025 | P250007 | Zenflow Spring® Implant and Delivery System | MER | 0 | December 11, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
Updated December 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.