510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921088Substantially Equivalent

Evacuator, Gastro-Urology

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

K921088 is the FDA 510(k) clearance record for EVACUATOR, GASTRO-UROLOGY, a class II device, cleared for Northgate Technologies, Inc. on under FDA product code KQT (Evacuator, Gastro-Urology). FDA records list 55 510(k) clearances for Northgate Technologies, Inc., from to . As of , FDA records show no recalls naming K921088.

Clearance record

Decision date
Received
(236 days to decision)
Product code
KQT Evacuator, Gastro-Urology
Regulation
21 CFR 876.4370
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Northgate Technologies, Inc. 3930 Ventura Dr., Arlington Heights IL
510(k) summary
Statement
Third party review
No

Clearances, product code KQT

Trailing 12 months

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

FDA records show no clearances under product code KQT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQT, 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 20260
October 20260