Kendall Curity Catheter Plug with Protective Cap
FDA 510(k) K951488 · The Kendal Co.
510(k) numberK951488
Submission
- Device name
- Kendall Curity Catheter Plug with Protective Cap
- Applicant
- The Kendal Co.
Mansfield, MA, US - Received
- March 31, 1995
- Decision date
- April 25, 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
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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 |
|---|---|---|
| K000087 | Marhukar Triple Lumen Catheter, Model 12 FRFOZ · Traditional | 03/17/2000SE |
| K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…EZL · Abbreviated | 09/28/1999SE |
| K991758 | Monoject Insulin SyringeFMF · Abbreviated | 06/14/1999SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | 04/23/1997SE |
| K942664 | Kendall Model 6325 SCD Sequel Compression SystemJOW · Traditional | 01/17/1995SE |
| K942774 | Polyskin(R) M.R. Moist Responsive Transparent DressingMGP · Traditional | 07/20/1994SN |
| K892434 | Kendall Curity Oxygen MaskBYG · Traditional | 08/15/1989SE |
| K892440 | Kendall Curity Extension TubesFPA · Traditional | 07/24/1989SE |
| K892438 | Kendall Curity Intravascular Cut Down TubesFPA · Traditional | 07/24/1989SE |
| K892436 | Kendall Curity Irrigation SyringeKOD · Traditional | 07/14/1989SE |
Questions and answers
When was Kendall Curity Catheter Plug with Protective Cap cleared by the FDA?
Kendall Curity Catheter Plug with Protective Cap (K951488) received a 510(k) decision of Substantially Equivalent on April 25, 1995, 25 days after the submission was received.
What is the product code of K951488?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.