Epimed International, Inc.
Johnstown, NY, US
EPIMED INTERNATIONAL, INC. appears in FDA device records in Johnstown, NY. FDA records list 16 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Epimed International, Inc. between 1998 and 2024. The busiest year on record is 2005, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 1 |
| 2008 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232632 | Racz Neurostat RF Generator | GXD | Substantially Equivalent | |
| K200624 | Percutaneous Introducer | BSO | Substantially Equivalent | |
| K190256 | Rulo Radiofrequency Lesion Probe | GXI | Substantially Equivalent | |
| 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 | |
| K072005 | RK EPIDURAL NEEDLE | BSP | Substantially Equivalent | |
| K053318 | RX EPIDURAL NEEDLE | BSP | Substantially Equivalent | |
| K051171 | STINGRAY EPIDURAL CATHETER CONNECTOR | CAZ | Substantially Equivalent | |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | MIA | Substantially Equivalent | |
| K043467 | FLEXIBLE SPINAL NEEDLE | BSP | Substantially Equivalent | |
| K041021 | RF INTRODUCTION CANNULA | GXI | Substantially Equivalent | |
| K041843 | PENCIL POINT NEEDLE | BSP | Substantially Equivalent | |
| K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 | BSO | Substantially Equivalent | |
| K030562 | TUOHY EPIDURAL NEEDLE | BSP | Substantially Equivalent | |
| K022029 | QUINCKE SPINAL NEEDLE | BSP | Substantially Equivalent | |
| K020926 | EXTENSION SET, MODELS 1911-512 | FPA | Substantially Equivalent | |
| K981329 | FETH-R-KATH | BSO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1316297 | 1316297 | EPIMED INTERNATIONAL, INC. | 141 SAL LANDRIO DR., JOHNSTOWN, NY 12095 US | 2026 | and 1 more, listed in full below |
| 1643059 | 1643059 | Epimed International, Inc. | 13958 Diplomat Drive, Dallas, TX 75234 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCEAdaptor, Catheter
- CAZAnesthesia Conduction Kit
- BSOCatheter, Conduction, Anesthetic
- GXHDevice, Surgical, Cryogenic
- GXDGenerator, Lesion, Radiofrequency
- MABMarker, Cardiopulmonary Bypass (Vein Marker)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- MIANeedle, Spinal, Short Term
- HNLProbe, Lachrymal
- GXIProbe, Radiofrequency Lesion
- FPASet, Administration, Intravascular
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1276-2021 | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 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 | Class II | Terminated | |
| Z-1850-2020 | R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain. | Incorrect expiration date on introduction cannula packaging. | Class II | Terminated | |
| Z-1849-2020 | R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain. | Incorrect expiration date on introduction cannula packaging. | Class II | Terminated | |
| Z-2069-2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 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. | Class II | Terminated | |
| Z-2068-2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, 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. | Class II | Terminated | |
| Z-2313-2021 | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Completed | |
| Z-2312-2021 | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Completed | |
| Z-0089-2018 | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only | Potential for partially incomplete seal of product, impacting sterility. | Class II | Terminated | |
| Z-0088-2018 | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile | Potential for partially incomplete seal of product, impacting sterility. | Class II | Terminated | |
| Z-0087-2018 | 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. | Class II | Terminated | |
| Z-0086-2017 | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain