Medical Device Manufacturer · US , Johnstown , NY

Epimed International, Inc.

14 submissions · 14 cleared · Since 1998
14
Total
14
Cleared
0
Denied

Epimed International, Inc. — FDA 510(k) Submissions

Epimed International, Inc. has submitted 14 FDA 510(k) premarket notifications since 1998, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Needle, Conduction, Anesthetic (w/wo Introducer), Catheter, Conduction, Anesthetic, Probe, Radiofrequency Lesion, Set, Administration, Intravascular, Anesthesia Conduction Kit . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Percutaneous Introducer
K200624 · BSO Catheter, Conduction,... · Anesthesiology
Apr 2020 48d
Rulo Radiofrequency Lesion Probe
K190256 · GXI Probe, Radiofrequency Lesion · Neurology
Mar 2019 29d
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
K133316 · BSO Catheter, Conduction,... · Anesthesiology
May 2014 212d
RX EPIDURAL NEEDLE
K053318 · BSP Needle, Conduction,... · Anesthesiology
Feb 2006 79d
STINGRAY EPIDURAL CATHETER CONNECTOR
K051171 · CAZ Anesthesia Conduction Kit · Anesthesiology
Aug 2005 112d
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
K051860 · MIA Needle, Spinal, Short Term · Anesthesiology
Aug 2005 45d
FLEXIBLE SPINAL NEEDLE
K043467 · BSP Needle, Conduction,... · Anesthesiology
Mar 2005 106d
RF INTRODUCTION CANNULA
K041021 · GXI Probe, Radiofrequency Lesion · Neurology
Sep 2004 149d
PENCIL POINT NEEDLE
K041843 · BSP Needle, Conduction,... · Anesthesiology
Aug 2004 47d
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
K023140 · BSO Catheter, Conduction,... · Anesthesiology
Aug 2003 329d
TUOHY EPIDURAL NEEDLE
K030562 · BSP Needle, Conduction,... · Anesthesiology
Apr 2003 41d
QUINCKE SPINAL NEEDLE
K022029 · BSP Needle, Conduction,... · Anesthesiology
Jul 2002 39d
EXTENSION SET, MODELS 1911-512
K020926 · FPA Set, Administration,... · General Hospital
Jul 2002 113d
FETH-R-KATH
K981329 · BSO Catheter, Conduction,... · Anesthesiology
Aug 1998 135d
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