POTRERO MEDICAL, INC.

FDA Device Registration & Listing · Hayward, CA, US · Registration 3011383638

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011383638
FEI Number
3011383638
Entity Name
POTRERO MEDICAL, INC.
City/State/Country
Hayward, CA, US
Establishment Address
26142 Eden Landing Road, Hayward, CA 94545, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Potrero Medical, Inc. (Owner Number: 10050934)
Owner / Operator Contact Address
26142 Eden Landing Road, Hayward, CA 94545, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K221020
PMA Number
N/A

All Registered Proprietary Names

Accuryn SmartFoley IAP UO Temp Tray System Accuryn Monitoring System AccuTab Accuryn SmartFoley UO Temp Tray System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2023-02-16
OUG Medical Device Data System General Hospital Class 1 880.6310 2023-02-16
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2023-02-16
PHU Intra-Abdominal Pressure Monitoring Device Unknown Class U N/A 2023-02-16

Official Correspondent

Ron Chavez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Potrero Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011383638. Last updated year: 2026. Please use registration number 3011383638 when referencing this establishment in official correspondence.
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