Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038284218

FEI Number

3038284218

Entity Name

Asensus Surgical Israel Ltd.

City/State/Country

Yokne'am Illit Northern, IL

Establishment Address

HaKadima, St. 9, Fibernet building, Floor #4, Yokne'am Illit Northern 2069206, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Asensus Surgical, Inc (Owner Number: 10029161)

Owner / Operator Contact Address

1001 Airport Blvd, Suite 110, Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212054

PMA Number

N/A

All Registered Proprietary Names

X9007741 Senhance Connect Senhance Senhance Ultrasonic System Senhance Senhance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWG	Camera, Television, Endoscopic, With Audio	General, Plastic Surgery	Class 1	878.4160	2021-02-15
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-03-10
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-07-18
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-01-18
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-10-28
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-06-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-10-28

Official Correspondent

Casey Hinckley

US Agent Details

Casey Hinckley Business: ASENSUS SURGICAL, INC Email: chinckley@asensus.com Phone: (801) 3105491

Related Public Records

Same Entity

Asensus Surgical, 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
3012880598	Asensus Surgical Italia, S.r.l.	Milano Lombardy, IT
3007593944	Asensus Surgical, Inc.	Morrisville, NC, US
3039523130	Asensus Surgical, Inc.	Durham, NC, US

Similar Registrations

Registration Number	Establishment Name	Location
9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE
2518897	PENTAX of America, Inc.	MONTVALE, NJ, US
3039523130	Asensus Surgical, Inc.	Durham, NC, US
3005527904	ATMOS INC.	Exton, PA, US
3008699634	INVENTIS SRL	Padova, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038284218. Last updated year: 2026. Please use registration number 3038284218 when referencing this establishment in official correspondence.