Data / Medical devices / United States / Epimed International, Inc.
Epimed International, Inc.: FDA-registered device maker in Johnstown, NY, United States, 18 510(k) clearances
Epimed International, Inc. is registered with the FDA (registration 1316297) in Johnstown, NY, United States. It lists 11 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
- 1316297
- Address
- 141 Sal Landrio DR. Crossroads Business Park, Johnstown, NY, United States, 12095
- Owner or operator
- Epimed International, Inc. (1316297)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, 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 | Manufacturer | accessdata.fda.gov |
| Catheter, Conduction, Anesthetic | BSO | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Surgical, Cryogenic | GXH | 2 | Manufacturer | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Cardiopulmonary Bypass (Vein Marker) | MAB | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Spinal, Short Term | MIA | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Contract manufacturer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | 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 1, 2021 | 87333 | Class II | Terminated | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: Intended for epidural anesthesia and is limited to placement of 72 hours or less | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off | accessdata.fda.gov |
| June 18, 2019 | 83247 | Class II | Terminated | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. | accessdata.fda.gov |
| April 22, 2016 | 74018 | Class II | Terminated | 15 g R.K. Epidural Needle (TW), Catalog #/REF # Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia | There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Catheter
- All makers of Marker, Cardiopulmonary Bypass (Vein Marker)
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Anesthesia Conduction Kit
- All makers of Probe, Lachrymal
- All makers of Catheter, Conduction, Anesthetic
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.