510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K180096Substantially Equivalent

GDT-1000 System

Acuvu, Inc., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180096 is the FDA 510(k) clearance record for GDT-1000 System, a class II device, cleared for Acuvu, Inc. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list one 510(k) clearance for Acuvu, Inc. As of , FDA records show no recalls naming K180096.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Acuvu, Inc. 1749 Broadway St., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260