Uresil Gastrostomy Catheter Kit , Model GCL-630HBK
FDA 510(k) K093653 · Uresil, LLC
510(k) numberK093653
Submission
- Device name
- Uresil Gastrostomy Catheter Kit , Model GCL-630HBK
- Applicant
- Uresil, LLC
Skokie, IL, US - Received
- November 25, 2009
- Decision date
- February 23, 2010
- Decision
- Unknown (SESK)
- 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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| 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 |
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| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
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| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
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More from Degania Silicone , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K053245 | GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter…FGE · Special | 12/20/2005SE |
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | 08/19/2004SE |
| K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP…FGE · Special | 01/04/2001SE |
| K980278 | Uresil Vascu-Flo Infusion CatheterDQY · Traditional | 11/20/1998SE |
| K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingLJE · Traditional | 09/10/1998SE |
| K980282 | Uresil Dilator with Radiopaque MarkerDRE · Traditional | 04/24/1998SE |
| K980889 | Uresil Nephro-Ureteral StentLJE · Traditional | 04/08/1998SE |
| K972582 | Uresil GuidewireFGE · Traditional | 11/21/1997SE |
| K972583 | Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary…FGE · Traditional | 08/29/1997SE |
| K953923 | Uresil Introducing NeedleKNW · Traditional | 09/08/1995SE |
Questions and answers
When was Uresil Gastrostomy Catheter Kit , Model GCL-630HBK cleared by the FDA?
Uresil Gastrostomy Catheter Kit , Model GCL-630HBK (K093653) received a 510(k) decision of Unknown on February 23, 2010, 90 days after the submission was received.
What is the product code of K093653?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.