ClearanceBrief
510(k) K172734 ยท FDI Snare, Flexible

Single Use Electrosurgical Snare SD-400

ApplicantOlympus Medical Systems Corp., Hachioji-Shi, JP
DecisionSubstantially Equivalent, Dec 7, 2017
ReceivedSep 11, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K172734

DateFirm and productCodeLinked 510(k)
Nov 7, 2025Olympus Corporation of the Americas
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to
Open, Classified
FDINone listed
Nov 7, 2025Olympus Corporation of the Americas
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instrument
Open, Classified
FDINone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal i
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injecti
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosa
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal inj
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal
Terminated
FGXNone listed

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