Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014683069

FEI Number

3014683069

Entity Name

Calyxo, Inc.

City/State/Country

Pleasanton, CA, US

Establishment Address

4473 Willow Road, 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

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
3032959393	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

Similar Registrations

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3010273872	Synergy Health AST, SRL	Alajuela, CR
1000121056	Boston Scientific Corporation	Coventry, RI, US
3013992977	OTU Medical Inc	Union City, CA, US
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014683069. Last updated year: 2026. Please use registration number 3014683069 when referencing this establishment in official correspondence.