FDA Product Code
FDA Product Code KGC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242211 | PUMA-G Pediatric System | Coaptech, Inc. | 2025-04-29 | Traditional | PDF ↗ |
| K223916 | PUMA-G System | Coaptech, Inc. | 2023-03-29 | Traditional | PDF ↗ |
| K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | 2020-03-12 | Traditional | PDF ↗ |
| K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019-09-30 | Traditional | PDF ↗ |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | 2019-06-26 | Traditional | PDF ↗ |
| K183057 | PUMA-G System | Coaptech, LLC | 2019-04-10 | Traditional | PDF ↗ |
| K170323 | Entuit Start Initial Placement Gastrostomy Set | Cook Incorporated | 2017-09-14 | Traditional | PDF ↗ |
| K120587 | AMT T-FASTENER ANCHOR KIT | Applied Medical Technology, Inc. | 2012-05-25 | Traditional | PDF ↗ |
| K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | Kimberly-Clark Corp. | 2009-12-08 | Special | PDF ↗ |
| K073718 | MEDLINE GASTROSTOMY TUBE | Medline Industries, Inc. | 2008-03-19 | Abbreviated | PDF ↗ |
| K080253 | KIMBERLY-CLARK INTRODUCER KITS | Kimberly-Clark Corp. | 2008-02-26 | Special | PDF ↗ |
| K980145 | AMT DECOMPRESSION TUBES | Applied Medical Technology, Inc. | 1998-04-10 | Traditional | PDF ↗ |
| K910492 | BARD REPLACEMENT GASTROSTOMY TUBE | C.R. Bard, Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K910584 | ONE STEP BUTTON(TM) | Applied Medical Technologies | 1991-05-23 | Traditional | PDF ↗ |
| K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | C.R. Bard, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE | Orion Life Systems, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K903086 | TUBE GASTROSTOMY | Knight Medical, Inc. | 1990-11-20 | Traditional | PDF ↗ |
| K903036 | P.R.G. GUIDEWIRE PLACEMENT SYSTEM | Applied Medical Technologies | 1990-11-19 | Traditional | PDF ↗ |
| K901791 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. | Southside Biotechnology | 1990-08-08 | Traditional | PDF ↗ |
| K901795 | GASTROSTOMY FEEDING CATHETER | Southside Biotechnology | 1990-08-08 | Traditional | PDF ↗ |
| K902121 | LAKE GASTROSTOMY TUBE | Lake Medical Products, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K900884 | P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY | Applied Medical Technologies | 1990-07-02 | Traditional | PDF ↗ |
| K901501 | CORPAK GASTROSTOMY TUBE | Corpak Co. | 1990-06-11 | Traditional | PDF ↗ |
| K894653 | NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR | Superior Biosystems, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K860441 | ENTROKIT WITH MAGLINTE CATHETER | Lafayette Pharmacal, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K781333 | CENTRAL CATHETER TRAY | Argon Medical Corp. | 1978-10-24 | Traditional | PDF ↗ |
Product code KGC · Class II · Gastroenterology, Urology. Data: openFDA.