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Sion Biotext Medical Ltd: FDA-registered device maker in Sderot Southern, Israel, 3 510(k) clearances

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

Sion Biotext Medical Ltd is registered with the FDA (registration 8030128) in Sderot Southern, Israel. It lists 15 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030128
FEI number: 3006118668
Address: 3 Eshel St, Sapirim Industrial Park, Sderot Southern, Israel, 8701002
Owner or operator: SION BIOTEXT MEDICAL LTD (8030128)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer
First device listed: October 1, 1996
Registered through: 2026
Brand names listed: Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(with x-ray detectable), Absorbent Surgical Gauze ball/Peanuts ball(with x-ray detectable), Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(with x-ray detectable); Non woven ball(with x-ray detectable), CerviLube, Non woven ball(with x-ray detectable), Non woven swab/Non woven pad(with x-ray detectable), Surgical Lap sponge/Abdominal sponge(with x-ray detectable), Surgical operation towel(with x-ray detectable)

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Cast	ITG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Degreaser, Skin, Surgical	KOY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
Wound Dressing Kit	MCY	2	Specification developer	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
December 23, 2015	K150676	L-Mesitran Dressing Family II- Soft and Tulle	FRO	Substantially Equivalent	Theo Manufacturing BV	accessdata.fda.gov
April 13, 2015	K142473	Lubricating Jelly	KMJ	Substantially Equivalent	Sion Biotext Medical , Ltd.	accessdata.fda.gov
July 12, 2012	K120812	RENAISSANCE	HAW	Substantially Equivalent	Mazor Robotics , Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 23, 2015. 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.