Prefilled Catheter Inflation Syringe
FDA 510(k) K112209 · Avail Medical Products, Inc.
510(k) numberK112209
Submission
- Device name
- Prefilled Catheter Inflation Syringe
- Applicant
- Avail Medical Products, Inc.
San Diego, CA, US - Received
- August 1, 2011
- Decision date
- September 8, 2011
- 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
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 |
| K090121 | Pre-Filled Catheter Inflation SyringeKNY · Special | Avail Medical Products, Inc. | 04/15/2009SE |
More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090121 | Pre-Filled Catheter Inflation SyringeKNY · Special | 04/15/2009SE |
| K083189 | Steri-Lub Lubrication GelKMJ · Special | 11/21/2008SE |
| K030149 | Medtronic Minimed Sof-Site Infusion Set, Models MMT-359S6, MMT-359M6, MMT-359L6…FPA · Traditional | 03/20/2003SE |
| K030137 | Medtronic Minimed Sof-Site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6…FPA · Traditional | 02/19/2003SE |
Questions and answers
When was Prefilled Catheter Inflation Syringe cleared by the FDA?
Prefilled Catheter Inflation Syringe (K112209) received a 510(k) decision of Substantially Equivalent on September 8, 2011, 38 days after the submission was received.
What is the product code of K112209?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.