Flexible Introducer Cannula, Model 135-1837
FDA 510(k) K051860 · Epimed International, Inc.
510(k) numberK051860
Submission
- Device name
- Flexible Introducer Cannula, Model 135-1837
- Applicant
- Epimed International, Inc.
Johnstown, NY, US - Received
- July 8, 2005
- Decision date
- August 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MIA – Needle, Spinal, Short Term
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
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| K970997 | Neo-Care Lumber Puncture KitMIA · Traditional | Klein-Baker Medical, Inc. | 05/22/1997SE |
| K961324 | Global Medical Products Spinal,Conical Tip (Sprottle Style), Whitacre Style NeedlesMIA · Traditional | Global Medical Prods, Inc. | 07/02/1996SE |
| K960405 | Spinal NeedleMIA · Traditional | Promex, Inc. | 02/28/1996SE |
| K942442 | Acufex T-Fix Delivery SystemMIA · Traditional | Acufex Microsurgical, Inc. | 12/05/1994SE |
| K904380 | Spinal Cord Access Epidural Introducer SystemMIA · Traditional | Custom Medical Concepts, Inc. | 04/08/1993SESK |
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| K190256 | Rulo Radiofrequency Lesion ProbeGXI · Traditional | 03/08/2019SE |
| K133316 | Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End…BSO · Traditional | 05/28/2014SE |
| K072005 | RK Epidural NeedleBSP · Traditional | 02/07/2008SE |
| K053318 | RX Epidural NeedleBSP · Traditional | 02/17/2006SE |
| K051171 | Stingray Epidural Catheter ConnectorCAZ · Traditional | 08/26/2005SE |
| K043467 | Flexible Spinal NeedleBSP · Traditional | 03/31/2005SE |
| K041021 | RF Introduction CannulaGXI · Traditional | 09/16/2004SE |
| K041843 | Pencil Point NeedleBSP · Traditional | 08/24/2004SE |
Questions and answers
When was Flexible Introducer Cannula, Model 135-1837 cleared by the FDA?
Flexible Introducer Cannula, Model 135-1837 (K051860) received a 510(k) decision of Substantially Equivalent on August 22, 2005, 45 days after the submission was received.
What is the product code of K051860?
The FDA product code is MIA – Needle, Spinal, Short Term, a Class II (moderate risk) device regulated under 21 CFR 868.5150.