Percutaneous Endoscopic Gastrostomy Kit
FDA 510(k) K885220 · Ethox Corp.
510(k) numberK885220
Submission
- Device name
- Percutaneous Endoscopic Gastrostomy Kit
- Applicant
- Ethox Corp.
Buffalo, NY, US - Received
- December 20, 1988
- Decision date
- September 25, 1989
- Decision
- Unknown (SEKD)
- 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 |
|---|---|---|
| K040286 | Ethox Surgi-Cuf Adult Disposable Blood Pressure CuffsDXQ · Abbreviated | 03/15/2004SE |
| K031195 | Cuf-Cover (TM)DXQ · Traditional | 10/10/2003SE |
| K962850 | Tum-E-VacKDH · Traditional | 02/21/1997SE |
| K935633 | No-MesKNT · Traditional | 09/30/1994SE |
| K921946 | Tum-E-Vac Bite BlockJXL · Traditional | 12/09/1992SE |
| K894927 | Surgi SqueezKZD · Traditional | 09/11/1989SE |
| K883977 | Surgi-Cuf Sterile/Non-Sterile DisposableDXQ · Traditional | 02/10/1989SE |
| K860599 | Ethox Lavage TubeKDH · Traditional | 03/11/1986SE |
| K844988 | Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.DXQ · Traditional | 04/04/1985SE |
| K841512 | Ethox Relia-Flo 2001 Enteral FeedFRN · Traditional | 05/21/1984SE |
Questions and answers
When was Percutaneous Endoscopic Gastrostomy Kit cleared by the FDA?
Percutaneous Endoscopic Gastrostomy Kit (K885220) received a 510(k) decision of Unknown on September 25, 1989, 279 days after the submission was received.
What is the product code of K885220?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.