510(k) · Cleared
ClearedMaverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serpex Medical · GEH Unit, Cryosurgical, Accessories
Cleared on Jun 30, 2026 as substantially equivalent to K190651 (Erbe Elektromedizin GmbH, 2020) after a 90-day review. Its family tree reaches back 4 generations to 1994. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 30, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934261 (1994). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK934261 Erbokryo CA Cryosurgical SystemErbe Elektromedizin GmbH · 1994
- 3 generations backK051509 Erbe Erbokryo CA Cryosurgical Unit & AccessoriesErbe USA, Inc. · 2005
- 2 generations backK151041 ERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc. · 2015
- 1 generation backK190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch…Erbe Elektromedizin GmbH · 2020 · Recalled (Class I)
- This deviceK261068 Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
Class I recalls in this family
- K190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal…direct predicate · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934261 | Erbokryo CA Cryosurgical System | Erbe Elektromedizin GmbH | 1994 | — |
| −3 | K051509 | Erbe Erbokryo CA Cryosurgical Unit & Accessories | Erbe USA, Inc. | 2005 | — |
| −2 | K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | Erbe USA, Inc. | 2015 | — |
| −1 | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable… | Erbe Elektromedizin GmbH | 2020 | Class I |
| 0 (this device) | K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…Summary page 5…Code GEH Legally Marketed Predicate ERBECRYO 2 Cryosurgical Unit and Accessories — Erbe Flexible Device Cryoprobes (K190651), cleared January 7, 2020 Device Description: The Maverix Cryo Biopsy (MCB) Probe (Model MCB-1000) is a sterile, single-use fle… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch…Erbe Elektromedizin GmbH · 2020 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K190651.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The Maverix CryoBiopsy (MCB) Probe is intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryo-adhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261068: Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261068
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026