Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
FDA 510(k) K190114 · Convatec Limited
510(k) numberK190114
Submission
- Device name
- Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
- Applicant
- Convatec Limited
Deeside, GB - Received
- January 24, 2019
- Decision date
- April 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNT
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|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | Convatec | 03/28/2025SE |
| K242336 | hygh-tec Drainage IIKNT · Traditional | Amb Medtec | 01/17/2025SE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
| K241169 | Entarik NI Feeding Tube SystemKNT · Traditional | Gravitas Medical, Inc. | 11/22/2024SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | Avanos Medical, Inc. | 10/25/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
More from Degania Silicone , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | 08/05/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | 04/01/2026SE |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…EZD · Traditional | 07/01/2025SE |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…FCM · Special | 06/06/2025SESK |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | 03/28/2025SE |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…EZD · Traditional | 01/25/2024SE |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed SystemEZD · Traditional | 11/08/2023SESK |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD · Traditional | 11/17/2022SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | 06/22/2022SE |
| K180205 | AVELLE Negative Pressure Wound Therapy SystemOMP · Traditional | 10/19/2018SE |
Questions and answers
When was Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) cleared by the FDA?
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (K190114) received a 510(k) decision of Substantially Equivalent on April 30, 2019, 96 days after the submission was received.
What is the product code of K190114?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.