Company · US

Calyxo, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (3 in 12 months)

1recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
FED	Endoscopic Access Overtube, Gastroenterology-Urology	3
FGB	Ureteroscope And Accessories, Flexible/Rigid	2

Decided	510(k)	Device and applicant	Code
Sep 15, 2026	K261447	CVAC® Aspiration System Calyxo, Inc.	FGB
Apr 13, 2026	K260965	CVAC Aspiration System Calyxo, Inc.	FED
Mar 6, 2026	K260013	CVAC Image Processor Calyxo, Inc.	FGB
Feb 2, 2024	K233472	CVAC Aspiration System + CVAC Image Processor Calyxo, Inc.	FED

Date	Firm and product	Code	Linked 510(k)
Mar 21, 2025	Calyxo, Inc. CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior. Open, Classified	FED	K233472