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)
Top companies in GEH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | Limitless Cryo Spa LLC Glypto Device, Glypto Cryo Machine; Open, Classified |
GEH | None listed |
| Aug 12, 2026 | Erbe USA Inc ERBECRYO 2 Cryosurgical Unit
Model/Catalog Number: 10402-000 Open, Classified |
GEH | K190651 |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 2.4mm, L1.15mm)
REF: 20402-411. For surgical use Open, Classified |
GEH | K190651 |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 1.7mm, L1.15mm)
REF: 20402-410. For surgical use Open, Classified |
GEH | K190651 |
| Mar 20, 2026 | Erbe USA Inc Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm)
REF: 20402-401
STERILE EO. For surgical use Open, Classified |
GEH | K190651 |
| Sep 11, 2025 | Boston Scientific Corporation Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 Open, Classified |
GEH | K234002 |
| Sep 11, 2025 | Boston Scientific Corporation ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 Open, Classified |
GEH | K234002 |
| Apr 29, 2025 | Boston 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 |
GEH | None listed |
| Apr 29, 2025 | Boston 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 |
GEH | None listed |
| Apr 29, 2025 | Boston 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 |
GEH | None listed |
| Apr 29, 2025 | Boston 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 |
GEH | K232635 |
| Feb 5, 2025 | New Medical Technologies Gmbh Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517; Open, Classified |
GEH | K091721 |
| Feb 5, 2025 | New Medical Technologies Gmbh Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516; Open, Classified |
GEH | K091721 |
| Jan 31, 2024 | AtriCure, Inc. Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 Open, Classified |
GEH | K140058 |
| Jan 31, 2024 | AtriCure, Inc. Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 Open, Classified |
GEH | K140058 |
| Sep 29, 2023 | Icecure 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 |
GEH | K102360 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" He-Thaw Prostate Cryoablation Kit Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" Prostate Cryoablation Kit Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" i-Thaw" Prostate Cryoablation Kit Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation Five IceRod" i-Thaw" Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation Five IceSphere" Prostate Cryoablation Kit Completed |
GEH | None listed |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" Prostate Cryoablation Kit Completed |
GEH | K051052 |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" Prostate Cryoablation Kit Completed |
GEH | K010991 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" i-Thaw" Prostate Cryoablation Kit Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation Three IcePearl" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | K152133 |
| Nov 18, 2020 | Boston Scientific Corporation Three IceFORCE" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | K152133 |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | K152133 |
| Nov 18, 2020 | Boston Scientific Corporation IceFORCE" 2.1 CX Prostate Cryoablation Kit Completed |
GEH | K152133 |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 MRI Cryoablation Needle Completed |
GEH | K051052 |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 MRI 90 Cryoablation Needle Completed |
GEH | K051052 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 MRI Cryoablation Needle Completed |
GEH | K051052 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 MRI 90 Cryoablation Needle Completed |
GEH | K051052 |
| Nov 18, 2020 | Boston Scientific Corporation IceEDGE" 2.4 90p Cryoablation Needle Completed |
GEH | K111859 |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 Cryoablation Needle Completed |
GEH | K003065 |
| Nov 18, 2020 | Boston Scientific Corporation IceSeed" 1.5 90 Cryoablation Needle Completed |
GEH | K060144 |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 Cryoablation Needle Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 90 Cryoablation Needle Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 S 90 Cryoablation Needle Completed |
GEH | K141485 |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 Cryoablation Needle Completed |
GEH | K141485 |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 90 Cryoablation Needle Completed |
GEH | K141485 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 Cryoablation Needle Completed |
GEH | K051052 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 90 Cryoablation Needle Completed |
GEH | K060144 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 PLUS Cryoablation Needle Completed |
GEH | K110946 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 PLUS 90 Cryoablation Needle Completed |
GEH | K110946 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 i-Thaw" Cryoablation Needle Completed |
GEH | K060390 |
| Nov 18, 2020 | Boston Scientific Corporation IceSphere" 1.5 CX 90 Cryoablation Needle Completed |
GEH | K181741 |
| Nov 18, 2020 | Boston Scientific Corporation IceRod" 1.5 CX 90 Cryoablation Needle Completed |
GEH | K121251 |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX L 90 Cryoablation Needle Completed |
GEH | K162599 |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX Cryoablation Needle Completed |
GEH | K152133 |
| Nov 18, 2020 | Boston Scientific Corporation IcePearl" 2.1 CX 90 Cryoablation Needle Completed |
GEH | K152133 |
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