Data / Medical devices / United States / Gentell

Gentell: FDA-registered device maker in Bristol, PA, United States, 8 510(k) clearances

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

Gentell is registered with the FDA (registration 2530957) in Bristol, PA, United States. It lists 16 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 7, 2024. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Gentell

FDA registration number: 2530957
FEI number: 1000522686
Address: 180 Rittenhouse Circle, Bristol, PA, United States, 19007
Owner or operator: GENTELL (10026501)
Roles: Repackager or relabeler
First device listed: September 2, 2008
Registered through: 2027
Brand names listed: 2245-00C Closed-end pouch adhesive 1 piece clear 13/64mm, 2245-00W Closed-end pouch adhesive 1 piece opaque 13/64mm, 2250-00C Closed-end pouch without adhesive 1 piece clear 13/64mm, 2250-00W Closed-end pouch without adhesive 1 piece opaque 13/64mm, 2700-45C Closed-end 2 pouch pieces clear 45mm, 2700-45W Closed-end 2 pouch pieces opaque 45mm, 2700-57C Closed-end 2 pouch pieces clear 57mm, 2700-57W Closed-end 2 pouch pieces opaque 57mm and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Colostomy, Disposable	EZS	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Cement, Stomal Appliance, Ostomy	EZR	1	Repackager or relabeler	accessdata.fda.gov
Collector, Ostomy	EXB	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Repackager or relabeler	accessdata.fda.gov
Protector, Ostomy	EXE	1	Repackager or relabeler	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Repackager or relabeler	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
October 7, 2024	K240485	LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)	FRO	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
October 12, 2023	K231152	Collagen Wound Dressing	KGN	Substantially Equivalent	Winner Medical Co., Ltd.	accessdata.fda.gov
September 20, 2022	K213598	LUOFUCON Collagen Wound Dressing	KGN	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
February 14, 2013	K120181	LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM	FRO	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
October 26, 2012	K122325	SKINTEMP II	KGN	Substantially Equivalent	Human Biosciences, Inc.	accessdata.fda.gov
March 24, 2011	K110042	MANUKATEX	FRO	Substantially Equivalent	Manuka Medical Limited	accessdata.fda.gov
December 8, 2010	K102659	MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER	FRO	Substantially Equivalent	Manuka Medical Limited	accessdata.fda.gov
May 20, 2010	K092689	MANUKAPLI WOUND DRESSING	FRO	Substantially Equivalent	Manuka Medical Limited	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
March 26, 2020	85373	Class II	Ongoing	Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little o	During an FDA audit, it was discovered that the product was not properly registered with FDA.	accessdata.fda.gov
February 27, 2020	85034	Class II	Ongoing	Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers,	During an FDA audit, it was discovered that the product was not properly registered with FDA.	accessdata.fda.gov

Compare with other makers

Updated October 7, 2024. 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.