Cleared Traditional

K262420 - Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000)

Also marketed or referenced as:
Maverix Cryo Cartridge (CC-1000)

K262420 is an FDA 510(k) clearance for Maverix Cryo Biopsy Pro (MCB Pro) (MCBP..., manufactured by Serpex Medical. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K262420 · Serpex Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
48d
Days
Class 2
Risk

K262420 is an FDA 510(k) clearance for the Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000). Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Serpex Medical (Santa Clara, US). The FDA issued a Cleared decision on September 2, 2026 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Serpex Medical devices

FDA 510(k) Submission Details - K262420

510(k) Number K262420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2026
Decision Date September 02, 2026
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 227
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K262420.
ERBECRYO 2 Cryosurgical Unit and Accessories
K261806 · Erbe Elektromedizin GmbH · Jun 2026
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit
K253230 · Erbe Elektromedizin GmbH · Apr 2026
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
K252198 · Medical Brands Laboratories B.V. · Apr 2026
XSense Cryoablation System with CryoProbes
K260377 · IceCure Medical , Ltd. · Feb 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)
K251928 · Medinice S.A. · Feb 2026
Dr. Yglo Skin Tag Remover
K251524 · Theotclab Healthcare B.V. · Jan 2026