510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K021010Substantially Equivalent

Modified Cardiac Cryosurgical System, Models 6Tcs1 & 6Tcse

Varian Medical Systems, Inc., Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021010 is the FDA 510(k) clearance record for MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE, a class II device, cleared for Endocare, 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 238 510(k) clearances for Varian Medical Systems, Inc., from to . As of , FDA records show no recalls naming K021010.

Clearance record

Decision date
Received
(69 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
Endocare, Inc. 7 Studebaker, Irvine CA
510(k) summary
Summary PDF
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260