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
K970717Substantially Equivalent

Vapor-Tech Sled Electrode

Northgate Technologies Inc., Elgin IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970717 is the FDA 510(k) clearance record for VAPOR-TECH SLED ELECTRODE, a class II device, cleared for Northgate Technologies, Inc. on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list 55 510(k) clearances for Northgate Technologies, Inc., from to . As of , FDA records show no recalls naming K970717.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Northgate Technologies, Inc. 600 Church Rd., Elgin IL
510(k) summary
Summary
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