Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1056129

FEI Number

1000132436

Entity Name

ENDO-THERAPEUTICS, INC.

City/State/Country

CLEARWATER, FL, US

Establishment Address

15251 Roosevelt Blvd Ste 204, CLEARWATER, FL 33760, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENDO-THERAPEUTICS, INC. (Owner Number: 9006380)

Owner / Operator Contact Address

15251 ROOSEVELT BLVD., SUITE 204, Clearwater, FL 33760, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K800965

PMA Number

N/A

All Registered Proprietary Names

EndoTNeedle EndoTGrasper EndoTBrush EndoTExtractor Bioceps EndoTBasket Biopsy Brush EZ-Snare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-02-15
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2007-04-04
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2007-04-04
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2023-01-02
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-26
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-01-02
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2007-11-26
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-16
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-10-16

Official Correspondent

Susan Clairmont

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENDO-THERAPEUTICS, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923489	Cox Medical Ent., Inc.	COX DISPOSABLE RETRIEVAL DEVICES	1992-09-23
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1056129. Last updated year: 2026. Please use registration number 1056129 when referencing this establishment in official correspondence.