Data / Medical devices / United States / Gi Supply

Gi Supply: FDA-registered device maker in Mechanicsburg, PA, United States, 9 510(k) clearances

Name: Gi Supply FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gi Supply is registered with the FDA (registration 3014718111) in Mechanicsburg, PA, United States. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 15, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Gi Supply

FDA registration number: 3014718111
FEI number: 1000121355
Address: 5069 Ritter Road Suite 104, Mechanicsburg, PA, United States, 17055
Owner or operator: GI SUPPLY (9004474)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 17, 2008
Registered through: 2026
Brand names listed: BlueBloc, EverLift Submucosal Lifting Agent, GeneraBloc, JADA System, OmniBloc, Oxybloc, PediaBloc, RenovaRP Centesis Pump System and more

Devices it lists

Device	Product code	Class	Role	Source
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Intrauterine Tamponade Balloon	OQY	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Marker, Colon	NBG	2	Manufacturer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Manufacturer	accessdata.fda.gov
Submucosal Injection Agent	PLL	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 15, 2026	K253642	Jada System (Jada-2002)	OQY	Substantially Equivalent	Organon, LLC	accessdata.fda.gov
April 19, 2023	K221042	Renova RP Centesis Pump	BTA	Substantially Equivalent	Gi Supply, Inc.	accessdata.fda.gov
September 30, 2021	K212757	Jada System	OQY	Substantially Equivalent	Alydia Health	accessdata.fda.gov
September 30, 2020	K202376	EverLift Submucosal Lifting Agent	PLL	Substantially Equivalent	Gi Supply, Inc.	accessdata.fda.gov
August 28, 2020	K201199	Jada System	OQY	Substantially Equivalent	Alydia Health	accessdata.fda.gov
June 20, 2020	K191923	EverLift Submucosal Lifting Agent	PLL	Substantially Equivalent	Gi Supply	accessdata.fda.gov
February 18, 2000	K993951	SPOT ENDOSCOPIC MARKER	NBG	Substantially Equivalent	Chek-Med Systems	accessdata.fda.gov
February 14, 1997	K970187	RUNYON LARGE VOLUME PARACENTESIS KIT	LRO	Substantially Equivalent	Gi Supply	accessdata.fda.gov
October 4, 1993	K931044	OXY-BLOC	MNK	Substantially Equivalent	Gi Supply	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 28, 2016	73151	Class II	Terminated	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.	accessdata.fda.gov

Compare with other makers

Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.