Data / Medical devices / United States / Channel Medsystems

Channel Medsystems: FDA-registered device maker in Berkeley, CA, United States, 1 PMA approval

Name: Channel Medsystems FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Channel Medsystems is registered with the FDA (registration 3012018285) in Berkeley, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 28, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012018285
Address: 2919 7th Street, Berkeley, CA, United States, 94710
Owner or operator: Channel Medsystems (10055277)
Roles: Manufacturer
First device listed: April 3, 2019
Registered through: 2026
Brand names listed: Cerene Cryotherapy Device, Exhaust Collection Bag

Devices it lists

Device	Product code	Class	Role	Source
Device, Thermal Ablation, Endometrial	MNB	3	Manufacturer	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
March 28, 2019	P180032	Cerene® Cryotherapy Device	MNB	23	September 15, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 20, 2025	96485	Class II	Ongoing	Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitr	Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device	accessdata.fda.gov
May 3, 2024	94506	Class II	Ongoing	Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitr	Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).	accessdata.fda.gov

Compare with other makers

All makers of Device, Thermal Ablation, Endometrial

Updated September 15, 2026. 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.