FDA.reportPublic FDA data

510(k) K910492

Device
Bard Replacement Gastrostomy Tube
Applicant
C.R. BARD, INC.
510(k) number
K910492
Product code
KGC
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-24
Date received
1991-02-05
Regulation
876.5980
Classification name
Tube, Gastro-Enterostomy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN HOFFER
Address
111 Spring St. Murray Hill NJ US 07974 07974

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
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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
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