Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae
FDA 510(k) K973893 · Applied Medical Technologies
510(k) numberK973893
Submission
- Device name
- Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae
- Applicant
- Applied Medical Technologies
Cleveland, OH, US - Received
- October 14, 1997
- Decision date
- December 19, 1997
- 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
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 |
|---|---|---|
| K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceKNT · Traditional | 08/17/1998SE |
| K972478 | Pre-Loaded Replacement G-Tubes and AccessoriesKNT · Traditional | 02/09/1998SE |
| K971757 | Low Profile Feeding Set AccessoryKNT · Traditional | 11/07/1997SE |
| K971758 | Cauterization Smoke EvacuatorGEI · Traditional | 07/21/1997SE |
| K961345 | Domed Percutaneous Endoscopic Gastrostomy(P.E.G.) Feeding TubeKNT · Traditional | 09/17/1996SE |
| K960232 | Endoscopic Access DeviceGCJ · Traditional | 03/21/1996SE |
| K945618 | Gastrointestinal Tubes & AccessoriesKNT · Traditional | 10/12/1995SE |
| K946140 | PRG ButtonKNT · Traditional | 08/28/1995SE |
| K923488 | Gastranimal Percutaneous Replacement GastroomyKNT · Traditional | 07/20/1995SE |
| K923692 | Stoma Measuring DeviceKNT · Traditional | 05/07/1993SEKD |
Questions and answers
When was Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae cleared by the FDA?
Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae (K973893) received a 510(k) decision of Substantially Equivalent on December 19, 1997, 66 days after the submission was received.
What is the product code of K973893?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.