Company ยท US
Epimed International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2024. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2024 | K232632 | Racz Neurostat RF Generator Epimed International | GXD |
| Apr 27, 2020 | K200624 | Percutaneous Introducer Epimed International, Inc. | BSO |
| Mar 8, 2019 | K190256 | Rulo Radiofrequency Lesion Probe Epimed International, Inc. | GXI |
| 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) Epimed International, Inc. | BSO |
| Feb 7, 2008 | K072005 | RK EPIDURAL NEEDLE Epimed International | BSP |
| Feb 17, 2006 | K053318 | RX EPIDURAL NEEDLE Epimed International, Inc. | BSP |
| Aug 26, 2005 | K051171 | STINGRAY EPIDURAL CATHETER CONNECTOR Epimed International, Inc. | CAZ |
| Aug 22, 2005 | K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 Epimed International, Inc. | MIA |
| Mar 31, 2005 | K043467 | FLEXIBLE SPINAL NEEDLE Epimed International, Inc. | BSP |
| Sep 16, 2004 | K041021 | RF INTRODUCTION CANNULA Epimed International, Inc. | GXI |
| Aug 24, 2004 | K041843 | PENCIL POINT NEEDLE Epimed International, Inc. | BSP |
| Aug 15, 2003 | K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 Epimed International, Inc. | BSO |
| Apr 3, 2003 | K030562 | TUOHY EPIDURAL NEEDLE Epimed International, Inc. | BSP |
| Jul 30, 2002 | K022029 | QUINCKE SPINAL NEEDLE Epimed International, Inc. | BSP |
| Jul 12, 2002 | K020926 | EXTENSION SET, MODELS 1911-512 Epimed International, Inc. | FPA |
| Aug 26, 1998 | K981329 | FETH-R-KATH Epimed International, Inc. | BSO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2021 | Epimed International, Inc. 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 Terminated |
BSO | K954584 |
| Apr 16, 2020 | Epimed International 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 radiofreque Terminated |
GXI | K041021 |
| Apr 16, 2020 | Epimed International 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 radiofrequ Terminated |
GXI | K041021 |
| Jun 18, 2019 | Epimed International, Inc. 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 Terminated |
BSO | K023140 |
| Jun 18, 2019 | Epimed International, Inc. 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 Terminated |
BSO | K023140 |
| Dec 28, 2017 | Epimed International NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile Completed |
BSO | K981329 |
| Dec 28, 2017 | Epimed International NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile Completed |
BSO | K981329 |
| Jul 24, 2017 | Epimed International TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only Terminated |
OGE | K030562 |
| Jul 24, 2017 | Epimed International 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 Terminated |
OGE | K041843 |
| Jul 24, 2017 | Epimed International 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 Terminated |
OGE | K053318 |
| Apr 22, 2016 | Epimed International, Inc. 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 Terminated |
BSP | K072005 |