Amsure Enteral Delivery Pump Set with Spike
FDA 510(k) K992719 · Amsino Intl., Inc.
510(k) numberK992719
Submission
- Device name
- Amsure Enteral Delivery Pump Set with Spike
- Applicant
- Amsino Intl., Inc.
Pomona, CA, US - Received
- August 12, 1999
- Decision date
- January 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
|---|---|---|
| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | 12/19/2007SE |
| K974042 | Amsure Cleansing Enema SetFCE · Traditional | 12/19/1997SE |
| K973107 | Amsino I.V. Administration SetFPA · Traditional | 10/02/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | 09/10/1997SE |
| K971929 | Amsino Urinary Leg BagKNX · Traditional | 08/06/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | 03/18/1997SE |
| K950780 | Amsino Cervical ScraperHHT · Traditional | 07/25/1995SE |
| K951528 | Amsino Disposable Viginal SpeculumHIB · Traditional | 05/11/1995SE |
Questions and answers
When was Amsure Enteral Delivery Pump Set with Spike cleared by the FDA?
Amsure Enteral Delivery Pump Set with Spike (K992719) received a 510(k) decision of Substantially Equivalent on January 12, 2000, 153 days after the submission was received.
What is the product code of K992719?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.