510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190407Substantially Equivalent

CryoLab

Cryoconcepts LP, Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190407 is the FDA 510(k) clearance record for CryoLab, a class II device, cleared for Cryoconcepts LP on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 8 510(k) clearances for Cryoconcepts LP, from to . As of , FDA records show no recalls naming K190407.

Clearance record

Decision date
Received
(60 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cryoconcepts LP 205 Webster St.,, Bethlehem PA
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