510(k) K834351 · FGE Stents, Drains And Dilators For The Biliary Ducts

BILIARY INDWELLING STENT

Applicant	Hobbs Medical, Inc., Mchenry IL, US
Decision	Substantially Equivalent, Mar 22, 1984
Received	Dec 13, 1983
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K834351

Date	Firm and product	Code	Linked 510(k)
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6533 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6534 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6535 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6544 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6548 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6562 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6566 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6567 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6568 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6582 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent Catalog Number: 6584 Open, Classified	FGE	None listed
Oct 7, 2022	Hobbs Medical, Inc. Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541 Open, Classified	FGE	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.