510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923037Substantially Equivalent

Miles Sodium Method

Kulzer GmbH, Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923037 is the FDA 510(k) clearance record for MILES SODIUM METHOD, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code JOS (Electrode, Electrosurgical). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K923037.

Clearance record

Decision date
Received
(95 days to decision)
Product code
JOS Electrode, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Heraeus Kulzer, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Statement
Third party review
No

Clearances, product code JOS

Trailing 12 months

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

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