Data / Medical devices / Israel / Degania Silicone, Ltd.

Degania Silicone, Ltd.: FDA-registered device maker in DEGANIA BET Northern, Israel, 12 510(k) clearances

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

Degania Silicone, Ltd. is registered with the FDA (registration 8030107) in DEGANIA BET Northern, Israel. It lists 22 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 20, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Degania Silicone, Ltd.

FDA registration number: 8030107
FEI number: 7682
Address: Kibbutz, DEGANIA BET Northern, Israel, 1513000
Owner or operator: QMD (8030107)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: January 11, 1995
Registered through: 2027
Brand names listed: Cardivascular clamps, Cervical Ripening Balloon Catheter, DEGANIA SILICONE TOURNIQUET, Drape for PEG kit, GENTLE FEED NIPPLE SHIELDS, Gastrostomy Replacement Tube with Lubricant Jelly, Gentle feed nipple shields, IDENTI-LOOPS SILICLAMPS and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer	accessdata.fda.gov
Balloon Gastrostomy Tube Kit	PRP	2	Specification developer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Manufacturer	accessdata.fda.gov
Catheter, Upper Urinary Tract	EYC	2	Contract manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Contract manufacturer	accessdata.fda.gov
Catheter, Ventricular, General & Plastic Surgery	GBS	1	Manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Contract manufacturer	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Contract manufacturer	accessdata.fda.gov
Dilator, Cervical, Hygroscopic-Laminaria	HDY	2	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Manufacturer	accessdata.fda.gov
Percutaneous Replacement Gastrostomy Tube Kit	PSH	2	Manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Manufacturer	accessdata.fda.gov
Shield, Nipple	HFS	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov
Tube, Feeding	FPD	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Tubing, Fluid Delivery	FPK	2	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
March 20, 2026	K254170	Percutaneous Endoscopic Gastrostomy (PEG) Kit	PIF	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
May 31, 2024	K233591	Stylus	KNT	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
June 21, 2016	K152246	Aquarius Stoma Measuring Device	KNT	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
December 29, 2014	K143378	AQUARIUS Gastrostomy Replacement Tube	KNT	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
October 16, 2014	K141753	AQUARIUS NASAL FEEDING TUBE	PIF	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
July 28, 2014	K141631	AQUARIUS EXTENSION FEEDING SET	KNT	Unknown	Degania Silicone , Ltd.	accessdata.fda.gov
September 5, 2012	K122030	LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON	KNT	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
May 23, 2007	K070124	GASTROSTOMY REPLACEMENT TUBE, MODEL 253	KNT	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
March 26, 2007	K063442	ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR	EZL	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
July 9, 1998	K981956	DEGANIA SILICONE IDENTI LOOPS	DXC	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
November 6, 1995	K953864	SILCLEAR TUBING (MODIFICATION)	FPK	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
June 2, 1992	K920501	SILCLAMPS DEGANIA SILICONE	DXC	Substantially Equivalent	Puritas Health Care, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 2, 2019	84510	Class II	Terminated	Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.	Temperature deviation did not meet release specifications	accessdata.fda.gov
June 28, 2019	83287	Class II	Terminated	Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body ca	15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body	accessdata.fda.gov
June 21, 2018	80641	Class II	Terminated	Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in	The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.	accessdata.fda.gov
October 3, 2017	79199	Class III	Terminated	Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.	Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.	accessdata.fda.gov
January 31, 2017	76368	Class II	Terminated	Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.	Product sterility compromised due to breach of sterile barrier	accessdata.fda.gov

Compare with other makers

Updated March 20, 2026. 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.