FDA product code GEH: Unit, Cryosurgical, Accessories
GEH is the FDA product code for unit, cryosurgical, accessories. It is a Class II device, regulated under 21 CFR 878.4350 and reviewed by the General and Plastic Surgery panel. FDA has cleared 264 510(k) submissions under GEH, 41 in the last five years, from 103 different applicants. The average 510(k) review took 107 days (median 88); 109 days on average over the last three years. FDA has posted 106 recalls for GEH devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Cryosurgical, Accessories |
| Device class | Class II |
| Regulation | 21 CFR 878.4350 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 12 | 106 |
| 2018 | 6 | 96 |
| 2019 | 6 | 153 |
| 2020 | 8 | 130 |
| 2021 | 6 | 201 |
| 2022 | 6 | 141 |
| 2023 | 8 | 159 |
| 2024 | 9 | 89 |
| 2025 | 10 | 100 |
| 2026 | 8 | 138 |
Compare with all 510(k) review times · Search every GEH clearance
Top GEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Galil Medical , Ltd. | 22 | 2018-07-30 |
| CSA Medical, Inc. | 14 | 2020-12-07 |
| Endocare, Inc. | 13 | 2010-06-14 |
| Cryomedical Sciences, Inc. | 9 | 2001-08-22 |
| Cryosurgery, Inc. | 8 | 2025-10-16 |
98 more applicants have GEH clearances. See the full list in Caduvo.
Most recent GEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262420 | Serpex Medical | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | 2026-09-02 | 48 |
| K261068 | Serpex Medical | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | 2026-06-30 | 90 |
| K261806 | Erbe Elektromedizin GmbH | ERBECRYO 2 Cryosurgical Unit and Accessories | 2026-06-09 | 8 |
| K253230 | Erbe Elektromedizin GmbH | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | 2026-04-22 | 205 |
| K252198 | Medical Brands Laboratories B.V. | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | 2026-04-02 | 262 |
Recalls for GEH devices
106 product recalls in 34 recall events; 14 initiated in the last five years and 15 still open. Most recent: 2026-06-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 2 |
| 2020 | 50 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code GEH?
GEH is the FDA product code for unit, cryosurgical, accessories. It is a Class II device, regulated under 21 CFR 878.4350 and reviewed by the General and Plastic Surgery panel.
What device class is GEH?
Class II, regulation 21 CFR 878.4350. Typical premarket route: 510(k).
How long does a 510(k) take for product code GEH?
Across 264 cleared submissions the average was 107 days from receipt to decision (median 88).
Which companies have the most GEH clearances?
Galil Medical , Ltd. (22); CSA Medical, Inc. (14); Endocare, Inc. (13); Cryomedical Sciences, Inc. (9); Cryosurgery, Inc. (8).
Have GEH devices been recalled?
Yes: 106 product recalls across 34 recall events; the most recent began 2026-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code GEH
- Run a recall and safety report across every GEH manufacturer
- Watch product code GEH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times