Data / Medical devices / United States / Endo-Therapeutics, Inc.

Endo-Therapeutics, Inc.: FDA-registered device maker in Clearwater, FL, United States, 7 510(k) clearances

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

Endo-Therapeutics, Inc. is registered with the FDA (registration 1056129) in Clearwater, FL, United States. It lists 13 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 2, 2001. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1056129
FEI number: 1000132436
Address: 15251 Roosevelt Blvd Ste 204, Clearwater, FL, United States, 33760
Owner or operator: ENDO-THERAPEUTICS, INC. (9006380)
Roles: Contract manufacturer, Manufacturer
First device listed: February 15, 2007
Registered through: 2026
Brand names listed: Bioceps, Biopsy Brush, Catchem' Polyp Trap, EZ-Snare, EndoTBasket, EndoTBrush, EndoTGrasper, EndoTNeedle and more

Devices it lists

Device	Product code	Class	Role	Source
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Brush, Biopsy, General & Plastic Surgery	GEE	1	Manufacturer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Bronchoscope (Non-Rigid)	BWH	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Contract manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Contract manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	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
November 2, 2001	K012977	VARICES INJECTION NEEDLE	FBK	Substantially Equivalent	Endo-Therapeutics, Inc.	accessdata.fda.gov
November 5, 1993	K925392	BIOPSY FORCEPS	FCL	Substantially Equivalent	Endo-Therapeutics, Inc.	accessdata.fda.gov
May 8, 1980	K800973	M.R. ASSOC. HOT BIOPSY FORCEPS	KNS	Substantially Equivalent	Mr Associates, Inc.	accessdata.fda.gov
May 8, 1980	K800972	M.R. ASSOC. TRIPOD GRASPING FORCEPS	OCZ	Substantially Equivalent	Mr Associates, Inc.	accessdata.fda.gov
May 8, 1980	K800970	M.R. ASSOC. BASKET RETRIEVERS	OCZ	Substantially Equivalent	Mr Associates, Inc.	accessdata.fda.gov
May 8, 1980	K800966	M.R. ASSOC. CYTOLOGY BRUSHES	FDX	Substantially Equivalent	Mr Associates, Inc.	accessdata.fda.gov
May 8, 1980	K800965	M.R. ASSOC. SNARES; CRESCENT SNARE WIRE	KNS	Substantially Equivalent	Mr Associates, 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
October 24, 2022	91074	Class II	Terminated	eSuction Small Cavity, Model ET2005	Improper device regulatory classification	accessdata.fda.gov

Compare with other makers

Updated November 18, 2022. 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.