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510(k) K131700 · FDI Snare, Flexible

SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES

Applicant	Boston Scientific Corp, Marlboro MA, US
Decision	Substantially Equivalent, Nov 4, 2013
Received	Jun 11, 2013
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K131700

Date	Firm and product	Code	Linked 510(k)
Jan 19, 2021	Boston Scientific Corporation Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring hand Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring hand Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring hand Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring hand Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring hand Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner Open, Classified	FDI	None listed
Jul 6, 2020	Boston Scientific Corporation Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring hand Open, Classified	FDI	None listed

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