FDA 510(k)

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

K-Number: K232635 · 2023-11-22

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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2023-11-22 under 510(k) 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. The listed applicant is Boston Scientific. The 510(k) number is K232635.

When did IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) receive FDA 510(k) clearance?

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 510(k) number K232635.

Who is the listed applicant for IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

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

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

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