510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974320Substantially Equivalent

Cryogen Cardiac Cryosurgical System

Cryogen, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974320 is the FDA 510(k) clearance record for CRYOGEN CARDIAC CRYOSURGICAL SYSTEM, a class II device, cleared for Cryogen, Inc. on under FDA product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue). FDA's definition for product code OCL reads: "Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue". FDA records list 4 510(k) clearances for Cryogen, Inc., from to . As of , FDA records show no recalls naming K974320.

Clearance record

Decision date
Received
(78 days to decision)
Product code
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cryogen, Inc. 6199 Cornerstone Ct. E., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code OCL

Trailing 12 months

FDA records hold no clearances under product code OCL in the trailing twelve months.

FDA records show no clearances under product code OCL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260