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510(k) K120587

Device
AMT T-FASTENER ANCHOR KIT
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
510(k) number
K120587
Product code
KGC  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
2012-05-25
Date received
2012-02-27
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
ELIZABETH MEYER
Address
8000 Katherine Blvd. Brecksville OH US 44141 44141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K223916PUMA-G SystemCoaptech, Inc.2023-03-29
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
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

Legacy Summary#

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FDA Review#

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