Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1643059

FEI Number

1643059

Entity Name

Epimed International, Inc.

City/State/Country

Dallas, TX, US

Establishment Address

13958 Diplomat Drive, Dallas, TX 75234, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Epimed International, Inc. (Owner Number: 1316297)

Owner / Operator Contact Address

141 SAL LANDRIO DR., CROSSROADS BUSINESS PARK, Johnstown, NY 12095, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051171

PMA Number

N/A

All Registered Proprietary Names

Chiba Needle Quincke Spinal Needle Spirol Block Catheter R-F Cannula RX Epidural Needle Tuohy Epidural Needle RULO Radiofrequency Lesion Probe Racz Neurostat RF Generator RK Epidural Introducer Needle Day Needle Blunt Nerve Block Needle PainBlocker Extension Set Wiley Spinal Spirol Epidural Catheter Feth-R-Kath Tun-L-XL Tun-L-Kath Brevi STF Brevi-XL E-Kath Brevi-Kath Racz Epidural Catheter Catheter Connector Versa-Kath Nexus Catheter Connector Stingray Epidural Cath. Connector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-04-16
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2014-12-29
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2008-04-16
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2008-04-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-04-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-04-16
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2019-09-09
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2024-08-19
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-04-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-04-16
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2013-04-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-04-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-04-16
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2008-04-16
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2008-04-16
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-27
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2008-04-16
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Epimed International, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1316297	EPIMED INTERNATIONAL, INC.	JOHNSTOWN, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1643059. Last updated year: 2026. Please use registration number 1643059 when referencing this establishment in official correspondence.