Percutaneous Introducer
FDA 510(k) K200624 · Epimed International, Inc.
510(k) numberK200624
Submission
- Device name
- Percutaneous Introducer
- Applicant
- Epimed International, Inc.
Farmers Branch, TX, US - Received
- March 10, 2020
- Decision date
- April 27, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
Other 510(k)s with product code BSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241410 | EDEN ControlCathBSO · Traditional | Jmt Co., Ltd. | 02/13/2025SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | B.Braun Medical, Inc. | 09/15/2023SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | Teleflex Medical | 08/30/2023SE |
| K193664 | SubQKath Catheter and Needle SetBSO · Traditional | Hk Surgical | 09/09/2020SE |
| K191470 | C-CAT Anaesthesia Catheter kitBSO · Traditional | Cimpax Aps | 10/25/2019SE |
| K181782 | Medline Reinforced Epidural CatheterBSO · Traditional | Medline Industries, Inc. | 03/04/2019SE |
| 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 |
| K171193 | Certa CatheterBSO · Traditional | Ferrosan Medical Devices Sp. Z.O.O. | 12/18/2017SE |
More from Ferrosan Medical Devices Sp. Z.O.O.
| 510(k) | Device | Decision |
|---|---|---|
| K232632 | Racz Neurostat RF GeneratorGXD · Traditional | 05/24/2024SE |
| 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 |
| 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 Percutaneous Introducer cleared by the FDA?
Percutaneous Introducer (K200624) received a 510(k) decision of Substantially Equivalent on April 27, 2020, 48 days after the submission was received.
What is the product code of K200624?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.