Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030107

FEI Number

7682

Entity Name

DEGANIA SILICONE, LTD.

City/State/Country

DEGANIA BET Northern, IL

Establishment Address

KIBBUTZ, DEGANIA BET Northern 1513000, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QMD (Owner Number: 8030107)

Owner / Operator Contact Address

DEGANIA BET, Degania Bet, IL-Z 1513000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tubing Realize Gastric calibration Tube Silicone Bulb Reservoirs SIL-K IDENTI-LOOPS SILICLAMPS Gentle feed nipple shields GENTLE FEED NIPPLE SHIELDS Straight Scissors for PEG kit Cervical Ripening Balloon Catheter Drape for PEG kit Gastrostomy Replacement Tube with Lubricant Jelly Silicone thoracic catheter Peg Kit Looped Placement Wire for PEG kit Cardivascular clamps DEGANIA SILICONE TOURNIQUET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-02-04
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-02-04
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2007-12-05
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-11-29
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-05
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-02-18
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2019-08-13
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2006-08-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-01-24
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	1997-07-09
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-09-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-12-18
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	1995-05-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-12-05
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2007-12-05
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-24
HDY	Dilator, Cervical, Hygroscopic-Laminaria	Obstetrics/Gynecology	Class 2	884.4260	2011-09-12
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-05
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-11-24
PRP	Balloon Gastrostomy Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2026-02-18
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2024-02-18
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-03-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-03-23
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-11-24
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-02-04
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2015-02-04
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-02-04
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2000-12-18
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-05
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	1995-01-11

Official Correspondent

Tal Gafni

US Agent Details

Angie Doe Email: adoe@qmd.net Phone: (262) 8331571

Related Public Records

Same Entity

QMD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010958377	Biometrix sro	Samorin Bratislavsky, SK
3016099072	Shomrat Molds Ltd	Hatzor Haglilit Northern, IL
8030115	BIOMETRIX LTD.	JERUSALEM, IL
3005483737	DEGANIA MEDICAL DEVICES PVT. LTD.	GURGAON Haryana, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030107. Last updated year: 2026. Please use registration number 8030107 when referencing this establishment in official correspondence.