510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050454Substantially Equivalent

Omnitech Fulgurating Electrode

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

K050454 is the FDA 510(k) clearance record for OMNITECH FULGURATING ELECTRODE, a class II device, cleared for Omnitech Systems, Inc. on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list 6 510(k) clearances for Omnitech Systems, Inc., from to . As of , FDA records show no recalls naming K050454.

Clearance record

Decision date
Received
(94 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Omnitech Systems, Inc. 456 S. Cambell, Bldg. C, Valparaiso IN
510(k) summary
Statement
Third party review
No

Clearances, product code FAS

Trailing 12 months
1 clearance under product code FAS in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FAS, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260