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FDA 510(k)

ActivSight Intraoperative Imaging System

K-Number: K231344 · 2023-08-02

ApplicantActiv Surgical, Inc.
Decision Date2023-08-02
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ActivSight Intraoperative Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Activ Surgical, Inc.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K231344. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ActivSight Intraoperative Imaging System?

ActivSight Intraoperative Imaging System is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Activ Surgical, Inc.. The 510(k) number is K231344.

When did ActivSight Intraoperative Imaging System receive FDA 510(k) clearance?

ActivSight Intraoperative Imaging System received FDA 510(k) clearance on 2023-08-02, under 510(k) number K231344.

Who is the listed applicant for ActivSight Intraoperative Imaging System?

The FDA 510(k) record lists Activ Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ActivSight Intraoperative Imaging System?

The FDA product code for ActivSight Intraoperative Imaging System is OWN.

Other records listing Activ Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203550ActivSight Intraoperative Imaging System

Related Devices (Code: OWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

Official Source

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