Gi Supply

Mechanicsburg, PA, US

GI SUPPLY appears in FDA device records in Mechanicsburg, PA. FDA records list 10 510(k) clearances between 1992-03-27 and 2023-04-19, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 10 510(k) clearances for Gi Supply between 1992 and 2023. The busiest year on record is 1997, with 2. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Gi Supply, by decision year
Year	Clearances
1992	1
1993	1
1995	1
1997	2
2001	1
2003	1
2020	2
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K221042	Renova RP Centesis Pump	BTA	Substantially Equivalent	2023-04-19
K202376	EverLift Submucosal Lifting Agent	PLL	Substantially Equivalent	2020-09-30
K191923	EverLift Submucosal Lifting Agent	PLL	Substantially Equivalent	2020-06-20
K031360	GI SUPPLY BILIARY STENT	FGE	Substantially Equivalent	2003-09-24
K012411	HP-ONE	LYR	Substantially Equivalent	2001-09-25
K970187	RUNYON LARGE VOLUME PARACENTESIS KIT	LRO	Substantially Equivalent	1997-02-14
K970186	GI SUPPLY PARACENTESIS PUMP	BTA	Substantially Equivalent	1997-02-14
K944903	HP-FAST	LYR	Substantially Equivalent	1995-04-20
K931044	OXY-BLOC	MNK	Substantially Equivalent	1993-10-04
K915816	BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY	EOQ	Substantially Equivalent	1992-03-27

Registered establishments

FDA registered establishments for Gi Supply, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3014718111	1000121355	GI SUPPLY	5069 Ritter Road, Mechanicsburg, PA 17055 US	2026	BTA LRO MNK NBG OQY PLL

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1047-2016	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 Expiration Date: 2018/04	Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.	Class II	2016-01-28	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain