Product code GEH: 510(k) clearances and predicates
Product code GEH covers Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000). FDA lists 264 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
264 clearances on file under product code GEH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 8 |
| 2024 | 9 |
| 2025 | 10 |
| 2026 so far | 8 |
Recent clearances
Newest GEH clearances in the FDA index, with applicant and decision date:
- K262420, Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000), applicant Serpex Medical, decided 2026-09-02. FDA record
- K261068, Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000), applicant Serpex Medical, decided 2026-06-30. FDA record
- K261806, ERBECRYO 2 Cryosurgical Unit and Accessories, applicant Erbe Elektromedizin GmbH, decided 2026-06-09. FDA record
- K253230, ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe, applicant Erbe Elektromedizin GmbH, decided 2026-04-22. FDA record
- K252198, Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover), applicant Medical Brands Laboratories B.V., decided 2026-04-02. FDA record
- K260377, XSense Cryoablation System with CryoProbes, applicant IceCure Medical , Ltd., decided 2026-02-24. FDA record
- K251928, CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21), applicant Medinice S.A., decided 2026-02-13. FDA record
- K251524, Dr. Yglo Skin Tag Remover, applicant Theotclab Healthcare B.V., decided 2026-01-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000), ERBECRYO 2 Cryosurgical Unit and Accessories. Watch new GEH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code GEH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GEH clearances include Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000).
How many 510(k) clearances use product code GEH?
264 at the time this page was generated, from openFDA records.
How do I find a predicate device under GEH?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new GEH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.