Enteral Bag/Set
FDA 510(k) K880051 · Churchill Corp.
510(k) numberK880051
Submission
- Device name
- Enteral Bag/Set
- Applicant
- Churchill Corp.
Langhorne, PA, US - Received
- January 6, 1988
- Decision date
- April 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K880026 | Churchill 0.22 Micron Liquid Compact Filter SetsFPB · Traditional | 04/14/1988SE |
| K880025 | Churchill 0.22 Micron Liquid Filter SetsFPB · Traditional | 04/14/1988SE |
| K880027 | Churchill 1.2 Micron Liquid Filter SetFPB · Traditional | 04/13/1988SE |
| K872585 | Churchill-CathFOZ · Traditional | 10/15/1987SE |
| K870395 | Churchill Parenteral Nutrition Bag - EvaKPE · Traditional | 10/15/1987SE |
| K872124 | Churchill Albumin IV Administration SetFPA · Traditional | 10/13/1987SE |
| K872123 | Churchill TPN Administration SetFPA · Traditional | 10/09/1987SE |
| K872043 | Churchill Inter-Cardiac SuckerDWF · Traditional | 09/30/1987SE |
| K871084 | Nitroglycerine Pump SetFRN · Traditional | 07/16/1987SE |
| K871732 | Churchill-H Vented IV Set W/Metering ChambersFPA · Traditional | 06/15/1987SE |
Questions and answers
When was Enteral Bag/Set cleared by the FDA?
Enteral Bag/Set (K880051) received a 510(k) decision of Substantially Equivalent on April 14, 1988, 99 days after the submission was received.
What is the product code of K880051?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.