Data / Medical devices / United States / Epimed International, Inc.
Epimed International, Inc.: FDA-registered device maker in Dallas, TX, United States, 18 510(k) clearances
Epimed International, Inc. is registered with the FDA (registration 1643059) in Dallas, TX, United States. It lists 9 device types. The FDA files 18 510(k) clearances under its listings, the newest dated May 24, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1643059
- Address
- 13958 Diplomat Drive, Dallas, TX, United States, 75234
- Owner or operator
- Epimed International, Inc. (1316297)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 27, 1992
- Registered through
- 2026
- Brand names listed
- Blunt Access Cannula, Blunt Nerve Block Needle, Brevi STF, Brevi-Kath, Brevi-XL, Catheter Connector, Chiba Needle, Day Needle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Catheter | GCE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Anesthesia Conduction Kit | CAZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Conduction, Anesthetic | BSO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Device, Surgical, Cryogenic | GXH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Spinal, Short Term | MIA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 24, 2024 | K232632 | Racz Neurostat RF Generator | GXD | Substantially Equivalent | Epimed International | accessdata.fda.gov |
| April 27, 2020 | K200624 | Percutaneous Introducer | BSO | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| March 8, 2019 | K190256 | Rulo Radiofrequency Lesion Probe | GXI | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| May 28, 2014 | K133316 | SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) | BSO | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| February 7, 2008 | K072005 | RK EPIDURAL NEEDLE | BSP | Substantially Equivalent | Epimed International | accessdata.fda.gov |
| February 17, 2006 | K053318 | RX EPIDURAL NEEDLE | BSP | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| August 26, 2005 | K051171 | STINGRAY EPIDURAL CATHETER CONNECTOR | CAZ | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| August 22, 2005 | K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | MIA | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| March 31, 2005 | K043467 | FLEXIBLE SPINAL NEEDLE | BSP | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| September 16, 2004 | K041021 | RF INTRODUCTION CANNULA | GXI | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| August 24, 2004 | K041843 | PENCIL POINT NEEDLE | BSP | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| August 15, 2003 | K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 | BSO | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| April 3, 2003 | K030562 | TUOHY EPIDURAL NEEDLE | BSP | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| July 30, 2002 | K022029 | QUINCKE SPINAL NEEDLE | BSP | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| July 12, 2002 | K020926 | EXTENSION SET, MODELS 1911-512 | FPA | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| August 26, 1998 | K981329 | FETH-R-KATH | BSO | Substantially Equivalent | Epimed International, Inc. | accessdata.fda.gov |
| October 8, 1996 | K954584 | RACZ EPIDURAL CATHETER | BSO | Substantially Equivalent | Medic Evaluation Devices & Instruments Corp. | accessdata.fda.gov |
| April 30, 1986 | K854334 | PAINBLOCKER WA5000 | GXH | Substantially Equivalent | Wallach Surgical Devices, 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 |
|---|---|---|---|---|---|---|
| February 21, 2020 | 85339 | Class II | Terminated | R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: /(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion proced | Incorrect expiration date on introduction cannula packaging. | accessdata.fda.gov |
| December 28, 2017 | 88317 | Class II | Completed | NEO-KATH Epidural Catheter Set, REF, Sterile | Potential for stylet to protrude from the distal end of the catheter | accessdata.fda.gov |
| July 24, 2017 | 77842 | Class II | Terminated | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter | Potential for partially incomplete seal of product, impacting sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Conduction, Anesthetic
- All makers of Set, Administration, Intravascular
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Probe, Radiofrequency Lesion
- All makers of Generator, Lesion, Radiofrequency
- All makers of Device, Surgical, Cryogenic
Updated May 24, 2024. 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.