Kendall Curity 20 Gauge Continuous Epidual Anesthe
FDA 510(k) K930219 · Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) numberK930219
Submission
- Device name
- Kendall Curity 20 Gauge Continuous Epidual Anesthe
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US - Received
- January 15, 1993
- Decision date
- April 27, 1993
- 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
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 |
| K200624 | Percutaneous IntroducerBSO · Traditional | Epimed International, Inc. | 04/27/2020SE |
| 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 |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973763 | Kendall Curity Iodoform Packing StripEFQ · Traditional | 12/31/1997SE |
| K973511 | Kendall Curity Petrolatum GauzeFRO · Traditional | 12/16/1997SN |
| K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)FRO · Traditional | 12/15/1997SN |
| K973619 | Kendall Curity Non-Adhering DressingKMF · Traditional | 12/10/1997SN |
| K973509 | Kendall Curasorb ZN + MG Alginate Wound DressingKMF · Traditional | 12/04/1997SN |
| K973546 | Kendall Fast-Cath Pre Lubricated Urethral CatheterEZD · Traditional | 11/07/1997SE |
| K970266 | Kendall Hydrophilic Powder Wound DressingKGN · Traditional | 04/23/1997SN |
| K963446 | Kendall Dual Lumen CatheterMPB · Traditional | 03/18/1997SE |
| K964899 | Kendall Curity Ureteral CatheterEYB · Traditional | 02/07/1997SE |
| K964519 | Curity Thoracentesis TrayGCX · Traditional | 12/20/1996SE |
Questions and answers
When was Kendall Curity 20 Gauge Continuous Epidual Anesthe cleared by the FDA?
Kendall Curity 20 Gauge Continuous Epidual Anesthe (K930219) received a 510(k) decision of Substantially Equivalent on April 27, 1993, 102 days after the submission was received.
What is the product code of K930219?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.