510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003405Substantially Equivalent

Endoscopic Monopolar Forceps-Scissors, Emf-2000 to 2999,Endoscopics Monopolarfoeps-Graspers, Emf-3000 to 3999, Endoscopo

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

K003405 is the FDA 510(k) clearance record for ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO, a class II device, cleared for Highland / Marietta, Inc. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 2 510(k) clearances for Highland / Marietta, Inc. As of , FDA records show no recalls naming K003405.

Clearance record

Decision date
Received
(187 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Highland / Marietta, Inc. 6155 Heisley Rd., Mentor OH
510(k) summary
Summary
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, 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 20261
October 20260