ClearanceBrief
510(k) K153625 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology

Single Use Injector NM600/610

ApplicantOlympus Medical Systems Corp., Hachioji-Shi, JP
DecisionSubstantially Equivalent, Feb 12, 2016
ReceivedDec 18, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K153625

DateFirm and productCodeLinked 510(k)
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKNone listed

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