510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981464Substantially Equivalent

Omnitech Resectoscope Cutting Loop Electrode

Omnitech Systems, Inc., Valparaiso IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981464 is the FDA 510(k) clearance record for OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE, a class II device, cleared for Omnitech Systems, Inc. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 6 510(k) clearances for Omnitech Systems, Inc., from to . As of , FDA records show no recalls naming K981464.

Clearance record

Decision date
Received
(78 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
Omnitech Systems, Inc. 456 S. Cambell, Bldg. C, Valparaiso IN
510(k) summary
Statement
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