KGC — Tube, Gastro-Enterostomy Class II
FDA product code KGC covers "Tube, Gastro-Enterostomy", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K901791 | southside biotechnology | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. | August 8, 1990 |
| K901795 | southside biotechnology | GASTROSTOMY FEEDING CATHETER | August 8, 1990 |