PUMA-G System
FDA 510(k) K223916 · Coaptech, Inc.
510(k) numberK223916
Submission
- Device name
- PUMA-G System
- Applicant
- Coaptech, Inc.
Baltimore, MD, US - Received
- December 29, 2022
- Decision date
- March 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K080253 | Kimberly-Clark Introducer KitsKGC · Special | Kimberly-Clark Corp. | 02/26/2008SESK |
More from Kimberly-Clark Corp.
Questions and answers
When was PUMA-G System cleared by the FDA?
PUMA-G System (K223916) received a 510(k) decision of Substantially Equivalent on March 29, 2023, 90 days after the submission was received.
What is the product code of K223916?
The FDA product code is KGC – Tube, Gastro-Enterostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5980.