Cleared Traditional

GDT-1000 System (K180096) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180096 · Acuvu, Inc. · Obstetrics & Gynecology device
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Apr 2018
Decision
90d
Days
Class 2
Risk

K180096 is an FDA 510(k) clearance for the GDT-1000 System. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Acuvu, Inc. (Redwood City, US). The FDA issued a Cleared decision on April 16, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acuvu, Inc. devices

Submission Details

510(k) Number K180096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date April 16, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 93
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K180096.
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
K180752 · Corinth Medtech, Inc. · Jul 2018
HSW Resection Instruments
K173070 · Henke-Sass, Wolf GmbH · Jun 2018
MyoSure MANUAL Tissue Removal Device
K173901 · Hologic, Inc. · May 2018
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
K171113 · Lina Medical Aps · Jan 2018
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K172566 · Hologic, Inc. · Sep 2017
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · Smith & Nephew, Inc. · Nov 2016