KGC — Tube, Gastro-Enterostomy Class II
FDA Device Classification
Classification Details
- Product Code
- KGC
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242211 | coaptech | PUMA-G Pediatric System | April 29, 2025 |
| K223916 | coaptech | PUMA-G System | March 29, 2023 |
| K193612 | applied medical technology | AMT Suture Delivery System | March 12, 2020 |
| K191844 | fidmi medical | Fidmi Low Profile Enteral Feeding Device | September 30, 2019 |
| K182832 | cook incorporated | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | June 26, 2019 |
| K183057 | coaptech | PUMA-G System | April 10, 2019 |
| K170323 | cook incorporated | Entuit Start Initial Placement Gastrostomy Set | September 14, 2017 |
| K120587 | applied medical technology | AMT T-FASTENER ANCHOR KIT | May 25, 2012 |
| K093312 | kimberly-clark | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL A | December 8, 2009 |
| K073718 | medline industries | MEDLINE GASTROSTOMY TUBE | March 19, 2008 |
| K080253 | kimberly-clark | KIMBERLY-CLARK INTRODUCER KITS | February 26, 2008 |
| K980145 | applied medical technology | AMT DECOMPRESSION TUBES | April 10, 1998 |
| K910492 | c.r. bard | BARD REPLACEMENT GASTROSTOMY TUBE | July 24, 1991 |
| K910584 | applied medical technologies | ONE STEP BUTTON(TM) | May 23, 1991 |
| K904779 | c.r. bard | BUTTON REPLACEMENT GASTROSTOMY DEVICE | January 18, 1991 |
| K904801 | orion life systems | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE | January 16, 1991 |
| K903086 | knight medical | TUBE GASTROSTOMY | November 20, 1990 |
| K903036 | applied medical technologies | P.R.G. GUIDEWIRE PLACEMENT SYSTEM | November 19, 1990 |
| K901795 | southside biotechnology | GASTROSTOMY FEEDING CATHETER | August 8, 1990 |
| K901791 | southside biotechnology | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. | August 8, 1990 |