EPIMED INTERNATIONAL, INC.

FDA Device Registration & Listing · JOHNSTOWN, NY, US · Registration 1316297

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1316297
FEI Number
1316297
Entity Name
EPIMED INTERNATIONAL, INC.
City/State/Country
JOHNSTOWN, NY, US
Establishment Address
141 SAL LANDRIO DR., CROSSROADS BUSINESS PARK, JOHNSTOWN, NY 12095, US
Establishment Type(s)
Manufacture 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
N
Expiration Date (Year)
2026
510(k) Number
K023140
PMA Number
N/A

All Registered Proprietary Names

Racz Neurostat RF Generator R-F Cannula Wiley Spinal Percutaneous Introducer Spirol Epidural Catheter Day Needle Blunt Nerve Block Needle PainBlocker Extension Set Spirol Block Catheter Lacrimal Eye Probe Heart Rings Vein Graft Ring Markers RX Epidural Needle RULO™ Radiofrequency Lesion Probe Catheter Connector Tuohy Epidural Needle Versa-Kath

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2024-08-19
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
MIA Needle, Spinal, Short Term Anesthesiology Class 2 868.5150 2020-05-19
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2020-05-19
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 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
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2014-12-29
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2014-01-20
MAB Marker, Cardiopulmonary Bypass (Vein Marker) Cardiovascular Class 2 870.3450 2014-01-21
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
GCE Adaptor, Catheter General, Plastic Surgery Class 1 878.4200 1992-07-27
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

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
1643059 Epimed International, Inc. Dallas, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
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
K072702 Stryker Instruments, Instruments Div. STRYKER ANTIMIC CATHETER 2008-03-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0664-2020 Abbott Medical 2
Radiofrequency Grounding Pad, REF RF-DGP-L
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-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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2182269 St. Jude Medical, Atrial Fibrillation Division, Inc. Minnetonka, MN, US
1643059 Epimed International, Inc. Dallas, TX, US
3007997036 STRYKER MANUFACTURING KALAMAZOO Portage, MI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1316297. Last updated year: 2026. Please use registration number 1316297 when referencing this establishment in official correspondence.
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