510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992796Substantially Equivalent

Aspiration/irrigation Catheter, Model Ac-1000

Image-Guided Neurologics, Inc., Melbourne FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992796 is the FDA 510(k) clearance record for ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000, a class II device, cleared for Image-Guided Neurologics, Inc. on under FDA product code HCA (Catheter, Ventricular). FDA records list 22 510(k) clearances for Image-Guided Neurologics, Inc., from to . As of , FDA records show no recalls naming K992796.

Clearance record

Decision date
Received
(67 days to decision)
Product code
HCA Catheter, Ventricular
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Applicant
Image-Guided Neurologics, Inc. 2290 Eau Gallie Blvd., Melbourne FL
510(k) summary
Statement
Third party review
No

Clearances, product code HCA

Trailing 12 months

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

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