Bi-Flex Evo
FDA 510(k) K182144 · Promepla Sam
510(k) numberK182144
Submission
- Device name
- Bi-Flex Evo
- Applicant
- Promepla Sam
Monaco, MC - Received
- August 8, 2018
- Decision date
- September 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050)KNY · Traditional | Class Medical , Ltd. | 08/05/2026SE |
| 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 |
| K090121 | Pre-Filled Catheter Inflation SyringeKNY · Special | Avail Medical Products, Inc. | 04/15/2009SE |
More from Avail Medical Products, Inc.
Questions and answers
When was Bi-Flex Evo cleared by the FDA?
Bi-Flex Evo (K182144) received a 510(k) decision of Substantially Equivalent on September 7, 2018, 30 days after the submission was received.
What is the product code of K182144?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.