Cleared Special

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

K232635 · Boston Scientific · General & Plastic Surgery
Nov 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K232635 is an FDA 510(k) clearance for the IceSeed 1.5 CX 90? Needle (H7493967433170); IceSeed 1.5 CX S 90? Needle (H7493967233100), a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on November 22, 2023, 84 days after receiving the submission on August 30, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K232635 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2023
Decision Date November 22, 2023
Days to Decision 84 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

Similar Devices — GEH Unit, Cryosurgical, Accessories

All 258
XSense Cryoablation System with CryoProbes
K260377 · IceCure Medical , Ltd. · Feb 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
K251928 · Medinice S.A. · Feb 2026
Dr. Yglo Skin Tag Remover
K251524 · Theotclab Healthcare B.V. · Jan 2026
Focused Cryotherapy System
K250742 · Focused Cryo, Inc. · Dec 2025
CryoFreeze Wart and Skin Tag Remover
K253000 · Cryosurgery, Inc. · Oct 2025
TargetCool? (RM-DT02W)
K253114 · Recensmedical, Inc. · Oct 2025