CALYXO, INC.

FDA Device Registration & Listing · Pleasanton, CA, US · Registration 3032959393

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
3032959393
FEI Number
3032959393
Entity Name
CALYXO, INC.
City/State/Country
Pleasanton, CA, US
Establishment Address
4430 Rosewood Dr., Suite 100, Pleasanton, CA 94588, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Calyxo, Inc. (Owner Number: 10058093)
Owner / Operator Contact Address
4473 Willow Road, Suite 100, Pleasanton, CA 94588, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233472
PMA Number
N/A

All Registered Proprietary Names

CVAC Image Processor CVAC Aspiration System and CVAC Image Processor CVAC Aspiration System CVAC Image Processor (SW 1.5, K260013)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-02-15
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-02-15

Official Correspondent

Michael Nevares

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014683069 Calyxo, Inc. Pleasanton, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032959393. Last updated year: 2026. Please use registration number 3032959393 when referencing this establishment in official correspondence.
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