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FDA 510(k)

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter

K-Number: K232633 · 2023-11-28

ApplicantBoston Scientific
Decision Date2023-11-28
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2023-11-28 under approval number K232633. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter?

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Boston Scientific. The 510(k) number is K232633.

When was Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter approved by the FDA?

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter received FDA 510(k) clearance on 2023-11-28, under approval number K232633.

What company makes Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter?

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter is manufactured by Boston Scientific.

What is the FDA product code for Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter?

The FDA product code for Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter is KNS.

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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.

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