FDA.report

510(k) K231344

Device
ActivSight Intraoperative Imaging System
Applicant
Activ Surgical, Inc.
510(k) number
K231344
Product code
OWN
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-02
Date received
2023-05-09
Regulation
876.1500
Classification name
Confocal Optical Imaging
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Nicholas Child
Address
30 Thomson Pl. Boston MA US 02110 02110

FDA Registration Numbers

Source Documents

510(k) summary PDF

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