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CVAC Aspiration System

FDA UDI

Class II (US FDA UDI)

by Calyxo, Inc.

Identity

Trade Name
CVAC Aspiration System FDA UDI
Generic Name
Flexible video ureteroscope, single-use FDA UDI
Model / Reference
CVC127020R-1 FDA UDI

Identifiers

Primary DI / UDI-DI
00860005357741 FDA UDI
510(k) Number
K233472 FDA UDI
FDA Product Code
FGB FDA UDI
FED FDA UDI
GMDN Term
Flexible video ureteroscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Flexible video ureteroscope, single-useIntracorporeal lithotripsy suction system

CVAC Aspiration System by Calyxo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracorporeal lithotripsy suction system.

Cleared under the same submission

K233472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Calyxo, Inc.

Sources (1)

  • FDA UDI b55c7f46-2a6f-4e38-88e7-7b2ebded8b08 33 fields · synced Jun 8, 2026