510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770678Substantially Equivalent

Elc-Thermo-System

Cutter Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770678 is the FDA 510(k) clearance record for ELC-THERMO-SYSTEM, a class III device, cleared for Cutter Laboratories, Inc. on under FDA product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)). FDA records list 39 510(k) clearances for Cutter Laboratories, Inc., from to . As of , FDA records show no recalls naming K770678.

Clearance record

Decision date
Received
(44 days to decision)
Product code
KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Regulation
21 CFR 884.2982
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
Cutter Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KXZ

Trailing 12 months

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

FDA records show no clearances under product code KXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXZ, 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