510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003403Substantially Equivalent

Endoscopic Monopolareectrode, Model Eme- 1000 to 1999

Highland / Marietta, Inc., Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003403 is the FDA 510(k) clearance record for ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999, a class II device, cleared for Highland / Marietta, Inc. on under FDA product code JOS (Electrode, Electrosurgical). FDA records list 2 510(k) clearances for Highland / Marietta, Inc. As of , FDA records show no recalls naming K003403.

Clearance record

Decision date
Received
(187 days to decision)
Product code
JOS Electrode, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Highland / Marietta, Inc. 6155 Heisley Rd., Mentor OH
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOS, 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