Gi Supply

Medical device manufacturer in Mechanicsburg, PA.

10510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K221042Renova RP Centesis PumpBTA · Traditional 04/19/2023SE
K202376EverLift Submucosal Lifting AgentPLL · Special 09/30/2020SE
K191923EverLift Submucosal Lifting AgentPLL · Traditional 06/20/2020SE
K031360Gi Supply Biliary StentFGE · Traditional 09/24/2003SE
K012411Hp-OneLYR · Traditional 09/25/2001SE
K970187Runyon Large Volume Paracentesis KitLRO · Traditional 02/14/1997SE
K970186Gi Supply Paracentesis PumpBTA · Traditional 02/14/1997SE
K944903Hp-FastLYR · Traditional 04/20/1995SE
K931044Oxy-BlocMNK · Traditional 10/04/1993SE
K915816Bite Block/Mouthpiece for EndoscopyEOQ · Traditional 03/27/1992SE

Recalls

RecallProductInitiated
Z-1047-2016 Class IILarge Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots…Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal… 01/28/2016Terminated