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Humantouch Surgical Ltd.: FDA-registered device maker in Netanya Central, Israel, 6 510(k) clearances

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

Humantouch Surgical Ltd. is registered with the FDA (registration 3014579024) in Netanya Central, Israel. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 5, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014579024
Address: 4 Meir Ariel St., Netanya Central, Israel, 4250574
Owner or operator: HUMANTOUCH SURGICAL LTD (10092394)
Roles: Complaint file establishment, Manufacturer
First device listed: January 1, 2025
Registered through: 2026
Brand names listed: HX Device, HandX, HandX Instrument - Monopolar Spatula, HandX Monopolar Scissors, Handx Self-Righting Needle Holder, Monopolar Hook

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Surgical, Computer Controlled Instrument	NAY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 5, 2023	K223718	HandX Self-Righting Needle Holder	GCJ	Substantially Equivalent	Human Xtensions , Ltd.	accessdata.fda.gov
May 10, 2023	K230491	HandX Monopolar Scissors	GCJ	Substantially Equivalent	Human Xtensions , Ltd.	accessdata.fda.gov
January 12, 2023	K222011	HandX Instrument - Monopolar Spatula	GCJ	Substantially Equivalent	Human Xtensions , Ltd.	accessdata.fda.gov
September 13, 2021	K212214	HandX	GCJ	Substantially Equivalent	Human Xtensions , Ltd.	accessdata.fda.gov
February 1, 2021	K203603	Monopolar Hook	GCJ	Substantially Equivalent	Human Xtensions , Ltd.	accessdata.fda.gov
March 20, 2018	K173919	HX Device	GCJ	Substantially Equivalent	Human Extension , Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 5, 2023. 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.