Kendall Curity & Kenguard Red Rubber Urethral Cath
FDA 510(k) K881667 · The Kendal Co.
510(k) numberK881667
Submission
- Device name
- Kendall Curity & Kenguard Red Rubber Urethral Cath
- Applicant
- The Kendal Co.
Boston, MA, US - Received
- April 18, 1988
- Decision date
- August 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
More from Hollister Incorporated
| 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 |
| K951488 | Kendall Curity Catheter Plug with Protective CapKNY · Traditional | 04/25/1995SE |
| 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 |
Questions and answers
When was Kendall Curity & Kenguard Red Rubber Urethral Cath cleared by the FDA?
Kendall Curity & Kenguard Red Rubber Urethral Cath (K881667) received a 510(k) decision of Substantially Equivalent on August 12, 1988, 116 days after the submission was received.
What is the product code of K881667?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.