Cleared Traditional

ActivSight Intraoperative Imaging System (K231344) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231344 · Activ Surgical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
85d
Days
Class 2
Risk

K231344 is an FDA 510(k) clearance for the ActivSight Intraoperative Imaging System. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Activ Surgical, Inc. (Boston, US). The FDA issued a Cleared decision on August 2, 2023 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Activ Surgical, Inc. devices

Submission Details

510(k) Number K231344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2023
Decision Date August 02, 2023
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWN Confocal Optical Imaging

All 41
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K231344.
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1788 4K Camera System with Advanced Imaging Modality
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FloNavi Open Field Fluorescence Imaging System
K230407 · Guangdong Optomedic Technologies, Inc. · Jul 2023
L12 LED Light Source with AIM
K230754 · Stryker · Apr 2023
SmartSurgN Visualization System
K213943 · Smartsurgn Incorporated · Nov 2022