Catheter Plug/Protector
FDA 510(k) K896806 · Westmark, Sterile Packing Systems, Inc. (Sps)
510(k) numberK896806
Submission
- Device name
- Catheter Plug/Protector
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US - Received
- December 1, 1989
- Decision date
- February 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050)KNY · Traditional | Class Medical , Ltd. | 08/05/2026SE |
| K182144 | Bi-Flex EvoKNY · Special | Promepla Sam | 09/07/2018SE |
| K162356 | Vesair Cystoscopic SheathKNY · Special | Solace Therapeutics | 03/02/2017SE |
| K140441 | Bi-Flex Ureteral Access SheathKNY · Traditional | Promepla Sam | 06/17/2014SE |
| K140562 | Wijay Ez-Void External Catheter ValveKNY · Traditional | Leomed, LLC | 06/16/2014SE |
| K141252 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 06/09/2014SE |
| K131803 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 08/20/2013SE |
| K123170 | Vari-Pass Variable Length Access SheathKNY · Special | Olympus Surgical Technologies America | 02/04/2013SE |
| K120160 | Rocamed Rocaus PlatinumKNY · Traditional | Promepla Sam | 05/14/2012SE |
| K112209 | Prefilled Catheter Inflation SyringeKNY · Special | Avail Medical Products, Inc. | 09/08/2011SE |
More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896800 | Irrigation TrayKYZ · Traditional | 05/24/1990SESK |
| K896799 | Paracervical/Pudendal TraysCAZ · Traditional | 04/23/1990SE |
| K896559 | Infant Feeding TubeFPD · Traditional | 03/13/1990SE |
| K896794 | Specimen ContainerLIO · Traditional | 03/01/1990SE |
| K896798 | Tracheostomy TrayBTO · Traditional | 02/22/1990SE |
| K896797 | Suction Catheter KitBSY · Traditional | 02/16/1990SE |
| K896215 | Mercy Hip/Knee PackKKX · Traditional | 02/13/1990SE |
| K896804 | ManifoldGCX · Traditional | 02/08/1990SE |
| K896563 | Tubing ConnectorsGCX · Traditional | 02/06/1990SE |
| K896562 | StopcockGCX · Traditional | 02/06/1990SE |
Questions and answers
When was Catheter Plug/Protector cleared by the FDA?
Catheter Plug/Protector (K896806) received a 510(k) decision of Substantially Equivalent on February 26, 1990, 87 days after the submission was received.
What is the product code of K896806?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.