ClearanceBrief
Panels › General, Plastic Surgery › Product code GEH · Class 2

Unit, Cryosurgical, Accessories

Regulation 878.4350

9510(k)s in 12 months (264 all time)
5recalls in 12 months (107 all time)
87recalls that name a 510(k)
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Top companies in GEH

DateFirm and productCodeLinked 510(k)
Oct 2, 2026Limitless Cryo Spa LLC
Glypto Device, Glypto Cryo Machine;
Open, Classified
GEHNone listed
Aug 12, 2026Erbe USA Inc
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Open, Classified
GEHK190651
Mar 20, 2026Erbe USA Inc
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Open, Classified
GEHK190651
Mar 20, 2026Erbe USA Inc
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Open, Classified
GEHK190651
Mar 20, 2026Erbe USA Inc
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Open, Classified
GEHK190651
Sep 11, 2025Boston Scientific Corporation
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Open, Classified
GEHK234002
Sep 11, 2025Boston Scientific Corporation
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Open, Classified
GEHK234002
Apr 29, 2025Boston Scientific Corporation
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Open, Classified
GEHNone listed
Apr 29, 2025Boston Scientific Corporation
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Open, Classified
GEHNone listed
Apr 29, 2025Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Open, Classified
GEHNone listed
Apr 29, 2025Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Open, Classified
GEHK232635
Feb 5, 2025New Medical Technologies Gmbh
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Open, Classified
GEHK091721
Feb 5, 2025New Medical Technologies Gmbh
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Open, Classified
GEHK091721
Jan 31, 2024AtriCure, Inc.
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Open, Classified
GEHK140058
Jan 31, 2024AtriCure, Inc.
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Open, Classified
GEHK140058
Sep 29, 2023Icecure Medical Ltd
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)
Open, Classified
GEHK102360
Nov 18, 2020Boston Scientific Corporation
IceRod" He-Thaw Prostate Cryoablation Kit
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
IceSeed" Prostate Cryoablation Kit
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
IceRod" i-Thaw" Prostate Cryoablation Kit
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
Five IceRod" i-Thaw" Prostate Cryoablation Kit
Completed
GEHNone listed
Nov 18, 2020Boston Scientific Corporation
Five IceSphere" Prostate Cryoablation Kit
Completed
GEHNone listed
Nov 18, 2020Boston Scientific Corporation
IceRod" Prostate Cryoablation Kit
Completed
GEHK051052
Nov 18, 2020Boston Scientific Corporation
IceSeed" Prostate Cryoablation Kit
Completed
GEHK010991
Nov 18, 2020Boston Scientific Corporation
IceRod" i-Thaw" Prostate Cryoablation Kit
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Completed
GEHK152133
Nov 18, 2020Boston Scientific Corporation
Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
Completed
GEHK152133
Nov 18, 2020Boston Scientific Corporation
IcePearl" 2.1 CX Prostate Cryoablation Kit
Completed
GEHK152133
Nov 18, 2020Boston Scientific Corporation
IceFORCE" 2.1 CX Prostate Cryoablation Kit
Completed
GEHK152133
Nov 18, 2020Boston Scientific Corporation
IceSeed" 1.5 MRI Cryoablation Needle
Completed
GEHK051052
Nov 18, 2020Boston Scientific Corporation
IceSeed" 1.5 MRI 90 Cryoablation Needle
Completed
GEHK051052
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 MRI Cryoablation Needle
Completed
GEHK051052
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 MRI 90 Cryoablation Needle
Completed
GEHK051052
Nov 18, 2020Boston Scientific Corporation
IceEDGE" 2.4 90p Cryoablation Needle
Completed
GEHK111859
Nov 18, 2020Boston Scientific Corporation
IceSeed" 1.5 Cryoablation Needle
Completed
GEHK003065
Nov 18, 2020Boston Scientific Corporation
IceSeed" 1.5 90 Cryoablation Needle
Completed
GEHK060144
Nov 18, 2020Boston Scientific Corporation
IceSphere" 1.5 Cryoablation Needle
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
IceSphere" 1.5 90 Cryoablation Needle
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
IceSphere" 1.5 S 90 Cryoablation Needle
Completed
GEHK141485
Nov 18, 2020Boston Scientific Corporation
IceSphere" 1.5 Cryoablation Needle
Completed
GEHK141485
Nov 18, 2020Boston Scientific Corporation
IceSphere" 1.5 90 Cryoablation Needle
Completed
GEHK141485
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 Cryoablation Needle
Completed
GEHK051052
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 90 Cryoablation Needle
Completed
GEHK060144
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 PLUS Cryoablation Needle
Completed
GEHK110946
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 PLUS 90 Cryoablation Needle
Completed
GEHK110946
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 i-Thaw" Cryoablation Needle
Completed
GEHK060390
Nov 18, 2020Boston Scientific Corporation
IceSphere" 1.5 CX 90 Cryoablation Needle
Completed
GEHK181741
Nov 18, 2020Boston Scientific Corporation
IceRod" 1.5 CX 90 Cryoablation Needle
Completed
GEHK121251
Nov 18, 2020Boston Scientific Corporation
IcePearl" 2.1 CX L 90 Cryoablation Needle
Completed
GEHK162599
Nov 18, 2020Boston Scientific Corporation
IcePearl" 2.1 CX Cryoablation Needle
Completed
GEHK152133
Nov 18, 2020Boston Scientific Corporation
IcePearl" 2.1 CX 90 Cryoablation Needle
Completed
GEHK152133

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