Resectr Tissue Resection Device
K-Number: K191538 · 2020-01-16
ApplicantBoston Scientific Corporation
Decision Date2020-01-16
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Resectr Tissue Resection Device is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-01-16 under approval number K191538. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Resectr Tissue Resection Device?
Resectr Tissue Resection Device is a medical device that received FDA 510(k) clearance on 2020-01-16. It is manufactured by Boston Scientific Corporation. The 510(k) number is K191538.
When was Resectr Tissue Resection Device approved by the FDA?
Resectr Tissue Resection Device received FDA 510(k) clearance on 2020-01-16, under approval number K191538.
What company makes Resectr Tissue Resection Device?
Resectr Tissue Resection Device is manufactured by Boston Scientific Corporation.
What is the FDA product code for Resectr Tissue Resection Device?
The FDA product code for Resectr Tissue Resection Device is HIH.
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Official Source
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