FDA 510(k)

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares

K-Number: K202478 · 2020-10-08

Decision Date2020-10-08

Product CodeFDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K202478. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares?

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Boston Scientific Corporation. The 510(k) number is K202478.

When did Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares receive FDA 510(k) clearance?

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares received FDA 510(k) clearance on 2020-10-08, under 510(k) number K202478.

Who is the listed applicant for Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares?

The FDA product code for Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares is FDI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.