510(k) clearances

Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)

Serpex Medical · General, Plastic Surgery

K262420Substantially EquivalentTraditionalGEH
Open FDA's page for this record
Third party flag
N
City
Santa Clara
Advisory committee description
General, Plastic Surgery
Address 1
3350 Scott Blvd.
Address 2
Suite 37b
Statement or summary
Summary
Product code
GEH
Zip code
95054
Applicant
Serpex Medical
Decision date
2026-09-02
Decision code
SESE
Country code
US
Device name
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
Advisory committee
SU
Contact
Neil Zimmerman
K number
K262420
State
CA
Date received
2026-07-16
Review advisory committee
SU
Postal code
95054
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Unit, Cryosurgical, Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4350
Device class
2
Registration number
1417592, 2937707, 3003678543, 3004753330, 1526711, 3039443708, 3008262715, 3012913237, 3008309062, 3013283620, 3015895145, 3011307964, 3009470597, 3026606306, 3015612252, 3013077751, 3010885402, 3008797959, 3009762450, 3015733082, 9610614, 1450662, 3004099264, 3015309643, 2134265, 3042940623, 3013445151, 3012697079, 3005740500, 3002808022, 3007829657, 9613249, 3014527929, 3008252257, 3017820152, 3012627460, 1424263, 1811755, 3015177815, 3039443404 +70 more
FEI number
1000208912, 1417592, 2937707, 3003678543, 3004753330, 1526711, 3039443708, 3008262715, 3012913237, 3008309062, 3000215205, 3013283620, 3015895145, 3011307964, 3009470597, 3026606306, 3015612252, 3013077751, 3010885402, 3008797959, 3009762450, 3015733082, 2000004234, 1450662, 3004099264, 3015309643, 3042940623, 3001236277, 1000140327, 1000122656, 3005740500, 3002808022, 3007829657, 3014527929, 3008252257, 3017820152, 3012627460, 1811755, 3015177815, 3039443404 +70 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.