FDA.reportPublic FDA data

510(k) K223916

Device
PUMA-G System
Applicant
Coaptech, Inc.
510(k) number
K223916
Product code
KGC
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-29
Date received
2022-12-29
Regulation
876.5980
Classification name
Tube, Gastro-Enterostomy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jack Kent
Address
101 W. Dickman St. Suite 700 Baltimore MD US 21230 21230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242211PUMA-G Pediatric SystemCoaptech, Inc.2025-04-29
K193612AMT Suture Delivery SystemApplied Medical Technology, Inc.2020-03-12
K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.2019-09-30
K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook Incorporated2019-06-26
K183057PUMA-G SystemCoaptech, LLC2019-04-10
K170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated2017-09-14
K120587AMT T-FASTENER ANCHOR KITApplied Medical Technology, Inc.2012-05-25
K093312KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEMKimberly-Clark Corp.2009-12-08
K073718MEDLINE GASTROSTOMY TUBEMedline Industries, Inc.2008-03-19
K080253KIMBERLY-CLARK INTRODUCER KITSKimberly-Clark Corp.2008-02-26
K980145AMT DECOMPRESSION TUBESApplied Medical Technology, Inc.1998-04-10
K910492BARD REPLACEMENT GASTROSTOMY TUBEC.R. Bard, Inc.1991-07-24
K910584ONE STEP BUTTON(TM)Applied Medical Technologies1991-05-23
K904779BUTTON REPLACEMENT GASTROSTOMY DEVICEC.R. Bard, Inc.1991-01-18
K904801ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBEOrion Life Systems, Inc.1991-01-16