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Company · US

Gi Supply

FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2023. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (0 in 12 months)

1recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
BTA	Pump, Portable, Aspiration (Manual Or Powered)	2
LRO	General Surgery Tray	2
LYR	Helicobacter Pylori	2
PLL	Submucosal Injection Agent	2
EOQ	Bronchoscope (Flexible Or Rigid)	1
FGE	Stents, Drains And Dilators For The Biliary Ducts	1
MNK	Endoscopic Bite Block	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Apr 19, 2023	K221042	Renova RP Centesis Pump Gi Supply, Inc.	BTA
Sep 30, 2020	K202376	EverLift Submucosal Lifting Agent Gi Supply, Inc.	PLL
Jun 20, 2020	K191923	EverLift Submucosal Lifting Agent Gi Supply	PLL
Sep 24, 2003	K031360	GI SUPPLY BILIARY STENT Gi Supply	FGE
Sep 25, 2001	K012411	HP-ONE Gi Supply	LYR
Feb 14, 1997	K970187	RUNYON LARGE VOLUME PARACENTESIS KIT Gi Supply	LRO
Feb 14, 1997	K970186	GI SUPPLY PARACENTESIS PUMP Gi Supply	BTA
Apr 20, 1995	K944903	HP-FAST Gi Supply	LYR
Oct 4, 1993	K931044	OXY-BLOC Gi Supply	MNK
Mar 27, 1992	K915816	BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY Gi Supply	EOQ

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jan 28, 2016	Gi Supply Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiratio Terminated	LRO	K970187

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