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FDA 510(k)

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)

K-Number: K232635 · 2023-11-22

ApplicantBoston Scientific
Decision Date2023-11-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2023-11-22 under approval number K232635. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is a medical device that received FDA 510(k) clearance on 2023-11-22. It is manufactured by Boston Scientific. The 510(k) number is K232635.

When was IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) approved by the FDA?

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) received FDA 510(k) clearance on 2023-11-22, under approval number K232635.

What company makes IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is manufactured by Boston Scientific.

What is the FDA product code for IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

The FDA product code for IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is GEH.

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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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