510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905117Substantially Equivalent

Endoscope and Accessories

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

K905117 is the FDA 510(k) clearance record for ENDOSCOPE AND ACCESSORIES, a class II device, cleared for Northgate Technologies, Inc. on under FDA product code GCI (Laryngoscope, Endoscope). FDA records list 55 510(k) clearances for Northgate Technologies, Inc., from to . As of , FDA records show no recalls naming K905117.

Clearance record

Decision date
Received
(163 days to decision)
Product code
GCI Laryngoscope, Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Northgate Technologies, Inc. 3930 Ventura Dr., Arlington Heights IL
Third party review
No

Clearances, product code GCI

Trailing 12 months

FDA records hold no clearances under product code GCI in the trailing twelve months.

FDA records show no clearances under product code GCI in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260