Prefilled Syringe for Inflation of Foley Catheter
FDA 510(k) K952414 · Acacia Laboratories, Inc.
510(k) numberK952414
Submission
- Device name
- Prefilled Syringe for Inflation of Foley Catheter
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- May 23, 1995
- Decision date
- June 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K952419 | Sterigauze Gel DressingMGQ · Traditional | 07/26/1995SE |
| K952420 | Sterigauze Wet DressingKMF · Traditional | 07/12/1995SE |
| K951861 | Stericare Wound Care GelMGQ · Traditional | 07/11/1995SE |
| K951914 | Hydracare Absorbent Wound DressingKMF · Traditional | 05/15/1995SN |
| K950344 | Horizon Foley Catheterization Tray Without CatheterFCM · Traditional | 03/24/1995SEKD |
| K913408 | Sterile Plastic DrapeKKX · Traditional | 03/12/1992SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | 05/07/1990SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | 11/08/1989SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | 07/14/1989SE |
| K884055 | Surgi-Tag(Tm) Sterile Label SetsLYV · Traditional | 10/13/1988SE |
Questions and answers
When was Prefilled Syringe for Inflation of Foley Catheter cleared by the FDA?
Prefilled Syringe for Inflation of Foley Catheter (K952414) received a 510(k) decision of Substantially Equivalent on June 23, 1995, 31 days after the submission was received.
What is the product code of K952414?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.