Gentuity, LLC

Sudbury, MA, US

GENTUITY, LLC appears in FDA device records in Sudbury, MA. FDA records list 4 510(k) clearances between 2020-02-20 and 2025-01-31, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 1
Registered establishments: 2

510(k) clearance history

FDA records hold 4 510(k) clearances for Gentuity, LLC between 2020 and 2025. The busiest year on record is 2020, with 1. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Gentuity, LLC, by decision year
Year	Clearances
2020	1
2023	1
2024	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K242966	Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter	DQO	Substantially Equivalent	2025-01-31
K242239	HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))	NQQ	Substantially Equivalent	2024-08-16
K230620	Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter	DQO	Substantially Equivalent	2023-08-08
K192922	Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter	NQQ	Substantially Equivalent	2020-02-20

Registered establishments

FDA registered establishments for Gentuity, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011578544	3011578544	GENTUITY, LLC	142 North Road, Sudbury, MA 01776 US	2026	DQO NQQ ORD
3021630097	3021630097	GENTUITY, LLC	28 Crosby Drive, Bedford, MA 01730 US	2026	NQQ ORD

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1823-2026	Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;	The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.	Class II	2026-03-23	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain