Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models)
FDA 510(k) K133316 · Epimed International, Inc.
510(k) numberK133316
Submission
- Device name
- Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models)
- Applicant
- Epimed International, Inc.
Johnstown, NY, US - Received
- October 28, 2013
- Decision date
- May 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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| K173541 | EpinautBSO · Traditional | Imedicom Co., Ltd. | 08/24/2018SE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional | PAJUNK GmbH Medizintechnologie | 05/03/2018SE |
| K171584 | B. Braun Tear-Away Introducer NeedleBSO · Traditional | B.Braun Medical, Inc. | 12/22/2017SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232632 | Racz Neurostat RF GeneratorGXD · Traditional | 05/24/2024SE |
| K200624 | Percutaneous IntroducerBSO · Traditional | 04/27/2020SE |
| K190256 | Rulo Radiofrequency Lesion ProbeGXI · Traditional | 03/08/2019SE |
| 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 |
| K051860 | Flexible Introducer Cannula, Model 135-1837MIA · Traditional | 08/22/2005SE |
| 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 Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models) cleared by the FDA?
Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models) (K133316) received a 510(k) decision of Substantially Equivalent on May 28, 2014, 212 days after the submission was received.
What is the product code of K133316?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.