510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261068Substantially Equivalent

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

Serpex Medical, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261068 is the FDA 510(k) clearance record for Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000), a class II device, cleared for Serpex Medical on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 4 510(k) clearances for Serpex Medical, from to . As of , FDA records show no recalls naming K261068.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Serpex Medical 3350 Scott Blvd., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260