PNR · Enteral Syringes With Enteral Specific Connectors
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | PNR |
|---|---|
| Device Name | Enteral Syringes With Enteral Specific Connectors |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Classification Rationale
(1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health PTE., Ltd. | Apr 8, 2026 | SESE |
| K251585 | Profoject Enteral Feeding Syringe | CMT Health PTE., Ltd. | Jul 18, 2025 | SESE |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth | Dec 19, 2024 | SESE |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair Lgl | Oct 6, 2023 | SESE |
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | Aug 17, 2023 | SESE |
| K222155 | O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | Jiangsu Caina Medical Co.,Ltd | Sep 16, 2022 | SESE |
| K211661 | ENFit enteral syringes (NUTRIFIT) | Pentaferte Italia S.R.L. | Feb 28, 2022 | SESE |
| K211593 | Enteral Pump Syringe | Jiangsu Caina Medical Co.,Ltd | Sep 30, 2021 | SESE |
| K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | Aug 27, 2021 | SESE |
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | Jun 30, 2021 | SESE |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | Jun 28, 2021 | SESE |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | Apr 28, 2021 | SESE |
| K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | Oct 9, 2020 | SESE |
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | Jiangsu Shenli Medical Production Co., Ltd. | Sep 28, 2020 | SESE |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | Sep 12, 2020 | SESE |
| K190502 | ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co.,Ltd | Aug 6, 2019 | SESE |
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | Neomed, Inc. | Apr 30, 2019 | SESE |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd. | Nov 9, 2018 | SESE |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | Jiangsu Micsafe Medical Technology Co., Ltd. | Oct 11, 2018 | SESE |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Amsino International, Inc. | Mar 30, 2018 | SESE |
Top Applicants
- Covidien — 4 clearances
- Neomed, Inc. — 4 clearances
- Jiangsu Caina Medical Co.,Ltd — 3 clearances
- CMT Health PTE., Ltd. — 2 clearances
- Ningbo Tianyi Medical Appliance Co., Ltd. — 2 clearances
