P.R.G. Percutaneous Replacement Gastrostomy
FDA 510(k) K900884 · Applied Medical Technologies
510(k) numberK900884
Submission
- Device name
- P.R.G. Percutaneous Replacement Gastrostomy
- Applicant
- Applied Medical Technologies
Independence, OH, US - Received
- February 26, 1990
- Decision date
- July 2, 1990
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGC – Tube, Gastro-Enterostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242211 | PUMA-G Pediatric SystemKGC · Traditional | Coaptech, Inc. | 04/29/2025SE |
| K223916 | PUMA-G SystemKGC · Traditional | Coaptech, Inc. | 03/29/2023SE |
| K193612 | AMT Suture Delivery SystemKGC · Traditional | Applied Medical Technology, Inc. | 03/12/2020SE |
| K191844 | Fidmi Low Profile Enteral Feeding DeviceKGC · Traditional | Fidmi Medical, Ltd. | 09/30/2019SE |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetKGC · Traditional | Cook Incorporated | 06/26/2019SESK |
| K183057 | PUMA-G SystemKGC · Traditional | Coaptech, LLC | 04/10/2019SE |
| K170323 | Entuit Start Initial Placement Gastrostomy SetKGC · Traditional | Cook Incorporated | 09/14/2017SE |
| K120587 | Amt T-Fastener Anchor KitKGC · Traditional | Applied Medical Technology, Inc. | 05/25/2012SESK |
| K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…KGC · Special | Kimberly-Clark Corp. | 12/08/2009SE |
| K073718 | Medline Gastrostomy TubeKGC · Abbreviated | Medline Industries, Inc. | 03/19/2008SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceKNT · Traditional | 08/17/1998SE |
| K972478 | Pre-Loaded Replacement G-Tubes and AccessoriesKNT · Traditional | 02/09/1998SE |
| K973893 | Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring…KNT · Traditional | 12/19/1997SE |
| K971757 | Low Profile Feeding Set AccessoryKNT · Traditional | 11/07/1997SE |
| K971758 | Cauterization Smoke EvacuatorGEI · Traditional | 07/21/1997SE |
| K961345 | Domed Percutaneous Endoscopic Gastrostomy(P.E.G.) Feeding TubeKNT · Traditional | 09/17/1996SE |
| K960232 | Endoscopic Access DeviceGCJ · Traditional | 03/21/1996SE |
| K945618 | Gastrointestinal Tubes & AccessoriesKNT · Traditional | 10/12/1995SE |
| K946140 | PRG ButtonKNT · Traditional | 08/28/1995SE |
| K923488 | Gastranimal Percutaneous Replacement GastroomyKNT · Traditional | 07/20/1995SE |
Questions and answers
When was P.R.G. Percutaneous Replacement Gastrostomy cleared by the FDA?
P.R.G. Percutaneous Replacement Gastrostomy (K900884) received a 510(k) decision of Unknown on July 2, 1990, 126 days after the submission was received.
What is the product code of K900884?
The FDA product code is KGC – Tube, Gastro-Enterostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5980.